SEPTEMBER 2001

WEEK ENDING SEPTEMBER 1

PRODUCT AND CODE: Revo Scooter. The product is a three wheeled motorized scooter. The product has been designed for both indoor and outdoor use to clean and dry conditions. Model Information: SC60RRED, SC60RBLU, and SC60RYELModels: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow)

REASON: Scooter drive system may engage while parking brake is inactive.

MANUFACTURER: Shanghai Global Fabtech Plastic Products, Shanghai, China,

RECALLED BY: Pride Mobility Products Corp, Exeter, PA

DISTRIBUTION: Nationwide and Canada

QUANTITY: 1152 units

PRODUCT AND CODE: Ash Split Catheter with cuffs, Batch/Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490, M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710,

M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660, M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310.

REASON: Catheter fails to remain anchored to patient.

MANUFACTURER/RECALLING FIRM: Medical Components, INC., Harleysville, PA.

DISTRIBUTION: Nationwide

QUANTITY: 43292

WEEK ENDING SEPTEMBER 8

PRODUCT AND CODE: Ventak Prism Automatic Implantable Cardioverter Defibrillators, VR Model 1850, VR HE Models 1852 and 1857, DR Model 1851, and DR HE Models 1853 and 1858. Codes: Serial Numbers:

Ventak Prizm VR Model 1850: 103440-103442, 103447-103470, 103472-103473, 103475, 103479-103515, 103517-103847, 103849-103880, 103882-104235, 104237-104883, 104885- 104886, 104888, 104891-105008, 105010-105949, 105951-106009, 106012- 109299, 109301-109303, 109305-109845

Ventak Prizm DR Model 1851: 307946, 307972, 307976, 307988, 307995-308002, 308006-308007, 308009, 308011, 308016, 308019-308020, 308026-308028, 308030-308047, 308054, 308069-308075, 308077-308115, 308118-308146, 308148- 308155, 308158-308269, 308271-308285, 308288-308309, 308311-308320, 308322-308326, 308328-308388, 308390-308406, 388408-308431, 308433- 308434,308436-308437, 308439-308665, 308667-308699, 308701-308713, 308715-308747, 308749-308790, 308792-308825, 308827-388970, 308972-308989, 308991, 308993-309294, 309296-309509, 309511-309842, 309844-310083, 310085-310095, 310098-310101, 310104-310105, 310108-310111, 310128-310175, 310177-310222, 310224-310225, 310227-310248, 310251- 310307, 310309-310329, 310335-310337, 310341-310387, 310389-310409, 310411-310943, 310945-311423, 311425-312590, 312592-312815, 312817-313201, 313203-314612

Ventak Prizm VR HE Model 1852: 100000-100507

Ventak Prizm DR HE Model 1853: 300005-300011, 300013-300014, 300017, 300019-300020, 300022, 300031-300033, 300035, 300037-300038, 300045-300063, 300065-300066, 300068- 300150, 300152, 300154-300280, 300282-300286, 300288-300317. 300319-300324, 300326-301611

Ventak Prizm VR HE Model 1857: 500000-500123

Ventak Prizm DR HE Model 1858: 600000-600129

REASON: Devices could inappropriately go into Safety Mode limiting therapy.

MANUFACTURER/RECALLING FIRM: Guidant Corporation, Cardiac Pacemakers, St. Paul, MN.

DISTRIBUTION: Nationwide and World wide.

QUANTITY: 13,833 defibrillators

PRODUCT AND CODE: Infusion Pump. Model PC-1, 220V CE, with software versions 8.12 and 8.13, Marked “International Only”.

REASON: The devices have the potential for a motor stall thereby affecting fluid delivery.

MANUFACTURER/RECALLING FIRM: Alaris Medical Systems, Inc., San Diego, CA.

DISTRIBUTION: Argentina, Australia, Chile, China, Hong Kong, Malaysia, Netherlands, New Zealand, Peru, Singapore, South Korea, United Kingdom. Also, U.S. Defense Department under contracts V797P-4091A and SP0200-98-D-8002.

QUANTITY: 5820

PRODUCT AND CODE: Stryker Secure Med/Surg Bed, Model No. 3000-AC powered Hospital Bed; all units with serial numbers beginning with the first four digits 9505 through 9610.

REASON: The fasteners which hold the side rails can loosen over time and make the side rail unstable, which may allow a patient to fall out of bed.

MANUFACTURER/RECALLING FIRM: Stryker Corp., Kalamazoo, MI.

DISTRIBUTION: United States, Canada, Hong Kong, Mexico, Saudi Arabia, Ukraine, United Arab Emirates and the United Kingdom.

QUANTITY: 5442

PRODUCT AND CODE: Cryovale Allograft Heart Valve. CODE: 6193676

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: PA

QUANTITY: 1

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 3942406; Cryovalve Allograft Heart Valve, Model No. PV00, Serial No.3942392.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: CA and FL

QUANTITY: 2

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6064264; Cryovalve Allograft Heart Valve, Model No. PV00, Serial No. 6064272

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: NV and NM

QUANTITY: 2

PRODUCT AND CODE: Cryovalve Allograft Heart Valve; Model No.PV00, Serial No. 6197116.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: CO

QUANTITY: 1

PRODUCT AND CODE: Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6105661.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: NV

QUANTITY: 1

PRODUCT AND CODE: Cryovalve Allograft Heart Valve; Model No. AV00. Serial No.3988317.

REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA

DISTRIBUTION: IL

QUANTITY: 1

PRODUCT AND CODE: Model SkinMaster System; CODE: SkinMaster MD7 Skin Rejuvenation System and SkinMaster Beauty Pro 5 System.

REASON: The device failed to comply with 21 CFR 1040.11(a)(2) in that the units were introduced into commerce without safety labels and user information that comply with the Federal laser product performance standard, 21 CFR 1040.10 and 11.

MANUFACTURER/RECALLING FIRM: Sybaritic Inc./Symedex LLC, Minneapolis, MN

DISTRIBUTION: Nationwide.

QUANTITY: 150 SkinMaster MD7 Skin Rejuvenation System units and 50 SkinMaster Beauty Pro 5 System units

PRODUCT AND CODE: Gas machine for anesthesia. CODE: 4114586-001.

REASON: Reports of unintended PEEP greater than 20 cmH20, all occurring at same hospital.

MANUFACTURER/RECALLING FIRM: North American Drager, Telford, PA.

DISTRIBUTION: Nationwide and Canada.

QUANTITY: 464 units.

PRODUCT AND CODE: E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

CODES:

a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above

b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above

c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed.

REASON: Incorrect orientation of acquired patient data

MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc. Hoffman Estates, IL.

DISTRIBUTION: Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands.

QUANTITY: 109 units.

PRODUCT AND CODE: Baxter Interlink and Regular I.V. Sets; sterile, nonpyrogenic fluid path.

CODES:

a) Product code 2C5487, lot R212308

b) Product code 2C5493, lot R212373

c) Product code 2C5531, lots R211250, R211359, R211383,R211466, R211581

d) Product code 2C5543, lot R211565

e) Product code 2C5593, lot R211128

f) Product code 2C5641, lot U572784R

g) Product code 2C6509, lot U571232R

h) Product code 2C6511, lots U570747R, U570838R

i) Product code 2C6519, lots R207191, R207266, R207357, R208678, R211334, R211417, R211599, R211623

j) Product code 2C6521, lot U569509R

k) Product code 2C6537, lots R207167, R207209, R207217, R207225, R207233, R207308, R207324, R207340, R207381, R207456, R207522, R207654, R207712, R207852, R207969, R208017, R208066, R208645, R208686, R208744, R208785, R208835, R208843, R208884, R208934, R208959, R208983, R209007, R209031, R209049, R209130, R209163, R209213, R209312, R209445, R209585, R209684, R211136, R211201, R211300, R211367, R211433, R211516, R211672, R211730, R211755, R211813, R211946, R211979, R212001, R212035, R212092, R212134, R212142, R212167, R212217, R212316, R212324, R212365, R212415

l) Product code 2C6546, lots R208769, R208868, R208975, R209056, R211052, R211102, R212126, R212209

m) Product code 2C6571, lots R209148, R209239, R209338, R209452, R211276

n) Product code 2C6593, lots U570135R, U570192R, U570085R

o) Product code 2C6606, lots R209023, R209072, R209080

p) Product code 2C6607, lots U569392R, U572156R

q) Product code 2C6612, lots R207183, R207258, R207290, R210104, R210146

r) Product code 2C6723, lot U570531R

s) Product code 2C6757, lots U569012R, U569228R, U569301R, U569863R, U570291R, U571828R, U571984R

t) Product code 2C6891, lots U571570R, U571752R, U571943R, U573295R

u) Product code 2C7542, lot U568303R

v) Product code 2C7560, lots U571588R, U572347R

w) Product code 2C7562, lots U568964R, U571364R, U571489R

x) Product code 2C7564, lots U570440R, U570499R, U571273R, U571554R, U571968R, U572420R, U572479R

y) Product code 2C7566, lots U570267R, U570317R, U571760R, U572511R

z) Product code 2C7591, lot U571745R

aa) Product code 2C7617, lots U568568R, U568873R, U572305R

bb) Product code 2C9903, lot U568576R

cc) Product code 2C9907, lot U569160R

dd) Product code 2H6519, lots R210047, R210179, R210211

ee) Product code 2N3378, lots U573063R, U573451R, U573634R, U574012R, U574178R

ff) Product code 2N9191, lot U568543R

gg) Product code 3C0059, lot U573030R

hh) Product code 4C7773, lot U568535R

ii) Product code 4C7774, lot U568428R

jj) Product code 4C7776, lot U569384R

REASON: Pinholes in protector cap of luer lock.

MANUFACTURER/RECALLING FIRM: Baxter Productos Medicos Ltd. Cartago, CR

RECALLED BY: Baxter Healthcare Corp. Round Lake, IL

DISTRIBUTION: Nationwide and Canada, New Zealand, Australia and Japan.

QUANTITY: 2,480,964 sets.

PRODUCT AND CODE: Abbott LCx Probe System Chlamydia trachomatis Assay Amplification & Detection Kit; an in-vitro diagnostic.

list 09B11 - U.S. labeling and list 07A91 - rest of world labeling

CODES: list no.09B11 - U.S. labeling: lots 65731M300, 65738M300, 65739M300, 65740M300, 65741M300, 66518M100, 67421M100, 67956M200, 68579M200, 68580M200, 68581M200, 68744M200, 68748M200, 69246M100, 69403M100, 70681M200, 70683M200, 70685M200, 70686M200, 70687M200, 70688M200, 70689M200, 70784M300, 70785M300, 70786M300, 70787M300, 70788M300, 70790M300, 70793M300, 70983M300, 71040M200, 72249M200, 72264M200

list no. 07A91 - rest of world labeling: lots 65802M100, 66289M300, 66290M300, 67207M200, 67208M200, 67210M200, 67394M100, 67445M200, 68255M200, 68258M200, 69861M100, 69862M100, 70690M200, 70692M200, 70693M200, 70695M200, 70698M200, 70699M200, 72003M200, 72005M200, 72127M100, 72421M200, 72980M100

REASON: High negative control rates resulting in invalid runs and non-repeating positive.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park , IL

DISTRIBUTION: Nationwide and Brazil, Canada, Great Britain, Japan, Hong Kong, Taiwan, Austalia, and New Zealand.

QUANTITY: 37,957 kits.

PRODUCT AND CODE: AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20; an In Vitro diagnostic assay for the quantitative determination of vitamin B12. Codes: list 3C79-20, lots 71097M100 and 71098M100

REASON: Calibration failures and nonreproducible results.

MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL

DISTRIBUTION: Canada, Australia, England, Hong Kong, New Zealand and Singapore.

QUANTITY: 1549 kits

PRODUCT AND CODE: 7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set.

CODE: Catalog # MCTC730K, Lot #M029230

REASON: Mislabeled - incorrect priming volume

MANUFACTURER: Medical Components, Inc., Harleysville, PA

DISTRIBUTION: Nationwide and Argentina, Italy, Canada, Netherlands, and United Kingdom.

QUANTITY: 91 trays

PRODUCT AND CODE: MEDCOMP BIO-FLEX CS CATHETER (CS100)

CODES: Catalong #BFL-6 - lots: M813770, M819200, M820840, M902950, M903840, M907780, M915320M919550, M921320, M929930, M933270 and M936870.

Catalog #BFR-6CTT (left side) - lots: M912540, M919140, M932310, and M934780.

Catalog #BFR-6CTT (right side) - lots: M912550, M915330, M919130, M924550, M932320,M935480, M937950.

Catalog #BFR-6 - lots: M728810, M801970, M809360,M813780, M819050, M819980, M820830, M900800, M902960, M03830, M904290, M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450, M933260, M936500, M937960.

Catalog #BFR-70 - lot: M928700.

Catalog #BFS-6 - lot: M834100, M903280, M912650, M914740, M927830, and M928340.

Catalog #BFS-6CTT - lots: M912560, M931380 and M932530.

Catalog #TRAY 452 - lots: M912380, M916450, M919100, M924370, and M933050.

Catalog #TRAY 453 - lot: M912390.

REASON: Longitudinal slits

MANUFACTURER: Medical Components, Harleysville, PA

DISTRIBUTION: Hong Kong, Netherlands, Portugal, Hungary, Switzerland, Puerto Rico, united Kingdom, Sweden, and Thailand.

QUANTITY: 22876 catheters

PRODUCT AND CODE: Silicone catheters

CODE: All lots.

MANUFACTURER: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA

REASON: Resent instructions for silicone catheters - not to use iodine

DISTRIBUTION: Nationwide, Austria and Guam.

QUANTITY: Unknown

PRODUCT AND CODE: Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1

CODE: Version 5.1

MANUFACTURER: DADE BEHRING, INC., NEWARK, DE

REASON: Incorrect low results for a number of patient samples.

DISTRIBUTION: Nationwide

QUANTITY: 1696 units

PRODUCT AND CODE: Pride Jazzy Scooter.

CODES: 1100, 1104, 1120, 1170 and PHC1.

REASON: Tire exploded

MANUFACTURER: PRIDE MOBILITY PRODUCTS CORP., EXETER, PA

DISTRIBUTION: Nationwide and England, Brazil, China, Belgium, Italy, Murcia, and Austrailia.

QUANTITY: 61510 units

PRODUCT AND CODE: Revo Scooter.

CODES: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow).

REASON: Scooter drive system may engage while parking brake is inactive

MANUFACTURER/RECALLING FIRM: Shanghai Global Fabtech Plastic Products, Shanghai, China,

DISTRIBUTION: Nationwide and Liftgate, Ontario, Canada.

QUANTITY: 1152 units

PRODUCT AND CODE: Drager Vapor 2000 Sevoflurane Vaporizers

CODES: Catalog Number: 2000 Serial Numbers: ARPH-0485, ARPH-0484, ARPH-0483, ARPH-0482, ARPH-0481, ARPH-0480, ARPH-0473, ARPH-0470, and ARPH-0469.

REASON: Mislabeled - Sevoflurane labeled as Isoflurane

MANUFACTURER: DRAGER MEDIZINTECHNIK GMBH LUEBECK,

RECALLED BY: North American Drager Telford, PA

DISTRIBUTION: PA

QUANTITY: 3

PRODUCT AND CODE: Percutaneous Sheath Introducer Kit.

CODES: Catalog #AK-09800, Lots: RF0070524, RF0072194, RF0072195, RF0083177, RF0083178, RF0084453, RF0084454, RF0091533, and RF0091534.

Catalog #AK-09801, Lots: RF0084462, RF0089390, and RF0080612.

Catalog #AK-09803, Lots: RF0072212, RF0073195, and RF0084474.

Catalog #AK-09880, Lot: RF0072232.

REASON: Valve may leak under certain conditions

MANUFACTURER: ARROW INTL., INC., READING, PA

DISTRIBUTION: Nationwide and Bangkok, Canada, Helsinki, Tokyo.

QUANTITY: 18170

PRODUCT AND CODE: Colleague Single Channel Volumetric Infusion Pumps, Codes: Product code 2M8151, all serial numbers less than 10110001CS.

REASON: Battery related failures.

MANUFACTURER/RECALLING FIRM: Baxter Healthcare Corporation, Singapore, SN.

RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division, Round Lake, IL

DISTRIBUTION: Nationwide to hospitals.

QUANTITY: 80,000 pumps

PRODUCT AND CODE: Disposable Scalpels labeled as sterile.

CODE:

Size 10 scalpels - Lot # 2410

Size 11 scalpels - Lot # 2412

Size 12 scalpels - Lot # 2293

Size 15 scalpels - Lot # 2428

Size 20 scalpels - Lot # 2399

REASON: Packaging defect (weld seals)/sterility may be compromised.

MANUFACTURER/RECALLED BY: ZNC International Inc., Port Chester, NY.

DISTRIBUTION: NY , PA , OH , FL, MI, NC, IL, TX, WI .

QUANTITY: Lot # 2410: 87 boxes; Lot # 2412: 400 boxes; Lot #2293: 100 boxes; Lot #2428: 500 boxes; Lot #2399: 39 boxes.

PRODUCT AND CODE: Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs.

All products contain a label that states “SSIS Inc. Date **Lot # ** Hos Part # ** Part Description: ** Product has been EO Gas terilized.***” CODE: 3527

REASON: Sterility may be compromised.

MANUFACTURER: Unknown

RECALLED BY: Surgical Instrument Service & Savings, Inc. Sisters, OR,

DISTRIBUTION: OR.

QUANTITY: 12 pkgs saw blades; 7 high speed burrs, 12 twist drill bits, 7 burrs

PRODUCT AND CODE: Servo Ventilator, 300/300A

REASON: Failure of front panel potentiometers due to oxidation

MANUFACTURER: Siemens Elema AB Solna,

DISTRIBUTION: Nationwide

QUANTITY: 5273

PRODUCT AND CODE: Agilent Technologies (formerly Hewlett Packard Co.)(A)Anesthesia Monitoring Systems, M1165A, M1166A,

M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262

(B)Upgrade kits M1160A and M1170A with option LO1 Anesthesia Monitoring Systems, Models: M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Released C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S

Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262 Upgrade kits M1160A and M1170A with option LO1

REASON: Monitoring and alarm functions maybe temporarily disabled

MANUFACTURER: AGILENT TECHNOLGIES (HEWLETT-PACKARD GMBH) BOEBLINGEN, BADEN-WTTBG,

RECALLED BY: Agilent Technologies, Inc., Andover, MA

DISTRIBUTION: Nationwide, VA Medical Centers in CA, MO, GU,

QUANTITY: 8 devices; 152 kits

PRODUCT AND CODE: Ash Split Catheter with cuffs.

CODES: Batch Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490,

M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710, M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660,

M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310.

REASON: Catheter fails to remain anchored to patient.

RECALLED BY: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA

DISTRIBUTION: Nationwide

QUANTITY: 43292

PRODUCT AND CODE: Animas R1000 Insulin Pump, 00-02688-01, 00-02864-01,00-02871-01, 00-02938-01, 00-02945-01, 01-02865-

01, 01-02872-01,01-02939-01, 02-02859-01, 02- 02866-01, 02-002873-01, 02-02880-01, 03-02698-01, 03-02867-01, 03-02874-01, 04-02868-01, 04-02875-01, 04-02882-01, 05-02869-01, 05-02876-01, 05-02883-01, 05-02890-01,06-02884-01, 07-02878-01, 07-02885-01, 07-02892-01, 09-02887-01,09-02894-01, 10-02888-01, 10-02895-01, 11-02889-01, 11-02896-01,12-02897-01, 13-02898-01, 14-02899-01, 47-03002-01, 48-03003-01, 48-03010-01, 49-03004-01, 49-03011-01, 50-03012-01, 50-03100-01, 51-03013-01, 51-03101-01, 52-03014-01, 52-03021-01, 52-03102-01, 53-03008-01, 53-03015-01, 53-03022-01, 53-03110-01, 54-03009-01, 54-03111-01, 55-03017-01, 55-03024-01, 55-03105-01, 55-03112-01, 55-03200-01, 56-03018-01, 56-03025-01, 56-03032-01, 56-03106-01, 56-03113-01, 56-03120-01, 57-03026-01, 57-03033-01, 57-03040-01, 7-03114-01, 57-03121-01, 58-03027-01, 58-03034-01, 58-03108-01, 59-03028-01, 59-03035-01, 59-03042-01, 59-03116-01, 59-03123-01, 59-03130-01, 59-03204-01, 60-03036-01, 60-03043-01, 60-03050-01, 60-

03117-01, 60-03131-01, 61-03037-01, 61-03044-01, 61-03118-01, 61-03125-01, 62-03038-01, 62-03045-01, 62-03052-01, 62-03119-01, 62-03133-01, 63-

03039-01, 63-03046-01, 63-03053-01, 63-03127-01, 63-03134-01, 63-03141-01, 64-03047-01, 64-03054-01, 64-03128-01, 64-03135-01, 65-03048-01, 65-

03055-01, 65-03062-01, 65-03129-01, 65-03150-01, 66-03049-01, 66-03056-01, 66-03070-01, 66-03144-01, 67-03064-01, 67-03071-01, 67-03138-01, 68-

03058-01, 68-03072-01, 68-03139-01, 68-03146-01, 69-03059-01, 69-03066-01, 69-03073-01, 69-03080-01, 69-03147-01, 69-03154-01, 70-03037-01, 70-

03074-01, 70-03081-01, 71-03068-01, 71-03082-01, 71-03149-01, 72-03069-01, 72-03083-01, 73-03077-01, 73-03091-01, 73-03158-01, 73-03165-01, 74-

03078-01, 74-03085-01, 74-03092-01, 75-03079-01, 75-03086-01, 75-03093-01, 76-02710-01, 76-03087-01, 76-03094-01, 77-02528-01, 77-03088-01, 78-

02617-01, 78-02712-01, 78-03089-01, 78-03184-01, 79-02706-01, 79-02720-01, 79-02801-01, 79-03097-01, 80-02640-01, 80-03098-01, 80-03193-01, 81-

02708-01, 81-02722-01, 81-03099-01, 81-03187-01, 83-02629-01, 83-02900-01, 84-02651-01, 84-02718-01, 84-02901-01, 85-02733-01, 85-02902-01, 86-

02639-01, 86-02808-01, 86-02815-01, 86-02822-01, 86-02903-01, 86-02910-01, 87-02647-01, 87-02830-01, 87-02904-01, 87-02911-01, 88-02493-01, 88-

02736-01, 88-02824-01, 88-02905-01, 88-02912-01, 89-02670-01, 89-02744-01, 89-02751-01, 89-02906-01, 89-02913-01, 89-02920-01, 90-02488-01, 90-

02745-01, 90-02819-01, 90-02907-01, 90-02914-01, 91-02908-01, 91-02915-01, 91-02922-01, 92-02673-01, 92-02828-01, 92-02842-01, 92-02909-01, 92-

02916-01, 92-02923-01, 92-02930-01, 93-02667-01, 93-02917-01, 93-02924-01, 93-02931-01, 94-02851-01, 94-02918-01, 94-02925-01, 94-02932-01, 95-

02852-01, 95-02919-01, 95-02926-01, 95-02940-01, 96-02589-01, 96-02691-01, 96-02765-01, 96-02846-01, 96-02927-01, 96-02934-01, 96-02491-01, 97-

02692-01, 97-02854-01, 97-02861-01, 97-02928-01, 97-02942-01, 98-02686-01, 98-02767-01, 98-02848-01, 98-02862-01, 98-02943-01, 99-02863-01, 99-

08270-01, 99-02937-01, and 99-02944-01.

REASON: Infusion pumps may have defective vents causing unintentional dose of insulin

MANUFACTURER: Animas Corporation, Frazer, PA

DISTRIBUTION: Nationwide

QUANTITY: 239 units

PRODUCT AND CODE: OncoSeed Iodine 125 Seeds; a welded titanium capsule containing Iodine-125 absorbed onto a silver rod.

CODE: Model 6711, lot E9448C.

REASON: Mislabeled seeds.

MANUFACTURER/RECALLING FIRM: Medi-Physics, Inc. dba Nycomed Amersham Imaging, Arlington Heights, IL.

DISTRIBUTION: AL.

QUANTITY: 110 seeds.

PRODUCT AND CODE: A.T.S. Reusable Tourniquet Cuffs, Velcro Component, Part No. 650199, Lot Nos. 92299500, 92308600, 92313500,

92313600, 92313700, 92322200, 92322300, 92322400, 92322500, 92322600, 92322700, 92323000, 92323100, 92327600, 92328000, 92328100, 92328200, 92328500, 92328600;

REASON: The Velcro hook fastener component tore during use. Internal tensile strength testing showed that the Velcro component had approximately half of the tensile strength of a normal product.

MANUFACTURER/RECALLING FIRM: Zimmer, Inc., Statesville, NC.

DISTRIBUTION: Nationwide and to Spain, Germany, France, Belgium, England, Denmark, Italy, Finland, Singapore, Latin America, Israel, Middle East, Canada, Australia, Japan and Korea.

QUANTITY: 3124

PRODUCT AND CODE: PRESS MATE Advantage Vital Sign Monitor. Models 9861, 9871

CODE: Serial Numbers 310004 through 311135

REASON: The monitor may display erratic respiration rates and cause a false or no alarm.

MANUFACTURER/RECALLING FIRM: COLIN CORP. Komaki City, Japan

RECALLED BY: Colin Medical Instruments Corp., San Antonio, TX

DISTRIBUTION: Nationwide

QUANTITY: 963

PRODUCT AND CODE: Vitros Clinical Chemistry Cholesterol (CHOL) Slides, Coating 0309, Catalog No. 1669829,

Lot Numbers: 0823-0309-7912 0823-0309-8001 0823-0309-8002 0823-0309-8069 0823-0309-8070 0823-0309-8071 0823-0309-8108 0823-0309-8109 0823-0309-8232 0823-0309-8233 0823-0309-8234 0823-0309-8236 0823-0309-8243 0823-0309-8244 0823-0309-8343 0823-0309-8344 0823-0309-8345 0823-0309-8378 0823-0309-8379 0823-0309-8445 0823-0309-8446 0823-0309-8447 0823-0309-8457 0823-0309-8552 0823-0309-8553 0823-0309-8614 0823-0309-8615 0823-0309-8627 0823-0309-8628 0823-0309-8629 0823-0309-8672 0823-0309-8673 0823-0309-8675 0823-0309-8676 0823-0309-8677 0823-0309-8702 0823-0309-8703 0823-0309-8704 0823-0309-8762 0823-0309-8763

REASON: The use of the referenced product may result in positively biased results at high concentrations.

MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

DISTRIBUTION: Nationwide and Australia, Canada, France, Germany, India, Italy, Portugal, Singapore and the UK

QUANTITY: 12,620 packs-domestic; and 8,603 packs-international

PRODUCT AND CODE: Vitros Clinical Chemistry Specialty Diluent,Catalog No. 8559825, Lot No. Y1844.

REASON: Product is labeled with the incorrect expiration date of 31 May 2003. The correct expiration date is 31 May 2002.

MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

DISTRIBUTION: CA, FL, KS, MA, NY, OK, PA, SD, TX, VT, and WI. Product was shipped to three government facilites under contract #V797P-6565A. 1) Ellsworth AFB, SD 2) Walter Reed Army Med. Ctr., Washington, DC 3) Columbus AFB, Columbus, MS

QUANTITY: 48 boxes

PRODUCT AND CODE: Plastic Material (Buttons) used to make Rigid Gas Permeable Contact Lenses: Boston II (oprifocon A) Green.

Product No.1000-A, Lot No. 00264PTC001, Rigid Gas Permeable Lens for Daily Wear; Boston Equalens II (itafocon A) Green wit UV, Product No. 1500-A, Lot Nos. 00214PTC003, 99279PTC004, 99279PTC005, 99279PTC006, Rigid Gas Permeable Contact Lenses for Daily Wear or Extended Wear; Boston ES (enflufocon A) Green with UV, Product No. 2200-A, Lot Nos. 00236PTC001, 00264PTC002, Rigid Gas Permeable

Contact Lenses; Boston ES (enflufocon A) Gray with UV, Product No. 2200-G, Lot No. 00236PTC002, Rigid Gas Permeable Contact

Lenses; Boston XO (hexafocon A) Green with UV, Product No. 2300-A, Lot Nos. 00040PTC013, 00040PTC014, 00040PTC015, 00165PTC008, 00278PTC006, Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lenses for Daily Wear; Boston EO (enflufocon B) Green with UV, Product No. 2600-A, Lot Nos. 00222PTC006, 00313PTC002, Rigid Gas Permeable Contact Lenses.

REASON: The contact lenses contained D&C Yellow No. 11which is not approved for contact lens use.

MANUFACTURER/RECALLING FIRM: Polymer Technology (A Bausch & Lomb, Inc. Co.) Rochester, NY.

DISTRIBUTION: Nationwide and worldwide.

QUANTITY: 92,455 units

PRODUCT AND CODE: Behring Coagulation System (BCS) software version 2.2. CODES: Model OVIO03 Version 2.2

REASON: Leak of piston pump valve introduces air bubbles.

MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg

RECALLED BY: Dade Behring, INC., Newark, DE

DISTRIBUTION: NY, IL and MI.

QUANTITY: 3 units.

PRODUCT AND CODE: Five Dimension RxL Flex Reagent Cartridges. The product is composed of 1) Ferritin (FERR), 2) Human Chorionic

Gonadotropin (HCG), 3) Mass Creatine Kinase MB Isoenzyme (MMB), 4) Myoglobin, and 5) Prostate Specific Antigen (PSA). FERR has 120

tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30 tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120 tests/carton; 30 tests/cartridge. PAS has 120 tests/carton; 30 tests/cartridge. The product is sold by the cartridge or 4 cartridges per carton.

CODES: FERR Lot FR9351 exp. 12/17/99, FERR Lot IR0063 exp. 3/3/99, HCG Lot HP0177 exp. 6/25/00, MMB Lot FP0100 exp. 4/9/00, MMB Lot HN0178 exp. 6/26/00, MMB WA0190 exp. 7/8/00, MYO Lot FP0074 exp. 3/14/00, MYO Lot FN0074 exp. 3/14/00, PSA Lot WA0253 exp. 9/9/00, and PSA Lot HP0239 exp. 8/26/00.

REASON: Decline in stability following hydration.

MANUFACTURER/RECALLING FIRM: Dade Behring, Inc., Newark, DE.

DISTRIBUTION: Nationwide and Germany, Australia, Canada, and Belgium.

QUANTITY: 6447.

PRODUCT AND CODE: Canon CXDI-22 X-Ray Digital Radiography System; CODE: Serial Numbers: 200001 through 200037 (except 200036).

REASON: The exposure function may fail due to a blown fuse.

MANUFACTURER/RECALLING FIRM: Canon U.S.A., Inc., Lake Success, NY.

DISTRIBUTION: NJ, NY, NC, OH, FL, WA, CA, TX, HI.

QUANTITY: 27

PRODUCT AND CODE: IMMULITE 2000 Antithyroid peroxidase (Anti TPO) kit, Catalog Number L2KTO2 121.

CODE: Immulite 2000 Antithyroid Peroxidase (TPO), kit lot L2KT02 121.

REASON: Component mix-up. Wrong bead lot.

MANUFACTURER/RECALLING FIRM: Euro DPC United Kingdom.

RECALLED BY: Diagnostic Products Corp., Los Angeles, CA

DISTRIBUTION: AZ, CA, NY, NJ, OR, MI, NM, MO, Korea and Japan.

QUANTITY: 55.

PRODUCT AND CODE: MicroBioLogics Streptococcus bovis, Derivative of ATCC# 49147, Catalog Numbers 0631V, 0631S, and 0631P.

This product was packaged into 3 packaging configurations under the MicroBioLogics brand name:

1. Catalog number 0631V - A single vial that contains 10 individual LYFO-Disk pellets streptococcus bovis.

2. Catalog number 0631S - A canster with 10 individual KWIK-STIK units of streptococcus bovis.

3. Catalog number 0631P - A wrapped set that contains 2 individual KWIK-STIK units of streptococcus bovis.

Packaging configurations 2 and 3 are labeled for a private label distributor, PML Microbiologicals, Wilsonville, OR. That name and address appears at the top of the label, with the product identification below.

Recalled product in a fourth packaging configuration was made and labeled for HealthLink. It is individually-wrapped Kwik-Stik labeled

“HealthLink*** Cat # HL3480 (49147) S. bovis”. HealthLink is located in Jacksonville, FL. CODE: Lot numbers 63131 and 63132.

REASON: The product contains the wrong bacteria strain.

MANUFACTURER/RECALLING FIRM: MicroBioLogics, Inc., St. Cloud, MN.

DISTRIBUTION: Nationwide, Canada and South Africa.

QUANTITY: 462 bacteria pellets, packaged 1-10 per package.

PRODUCT AND CODE: EasyBlood Gas Analyzer.

CODES: EasyBlood Gas Analyzers with Software version below M4.20.

REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg.

MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA.

DISTRIBUTION: Malaysia, Russia, Hong Kong, Switzerland, Argentina, Czech Republic, Canada, Hungary, Chile Finland, Turkey, Italy, South Africa, Korea, Pakistan, Greece, Portugal, Mexico, Venezuela, Philippines, Bangladesh.

QUANTITY: 229.

PRODUCT AND CODE: Vaxcel 5F SL PICC(Peripherally Inserted Central Cannula), Clampable Hub Catalog #45-443, Lot Number 005827

Codes: Vaxcel 5F SL PICC (Peripherally Inserted Central Cannula), Clampable Hub, 60 cm Wire Catalog #45-443, Lot Number 005827.

REASON: Product may not have a clampable hub.

MANUFACTURER/RECALLING FIRM: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT.

RECALLED BY: MEDI TECH, a division of Boston Scientific Corp. Watertown, MA

DISTRIBUTION: Nationwide to Medical Centers.

QUANTITY: 699.

PRODUCT AND CODE: Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003;

Wako Lyophilized Chemistry 1, Product Code 1104A, Lot Number 7704A01, MFD Mar-00, Exp Date 31 Mar 2003

REASON: Unit recalled by component manufacturer due to positive for anti-HCV

MANUFACTURER/RECALLING FIRM: Bio-Rad Laboratories, Inc. Irvine, CA.

DISTRIBUTION: Japan.

QUANTITY: Unknown.

PRODUCT AND CODE: Bard InLay Ureteral Stent, 4.7 Fr. Diameter.CODES: Catalog Number 777424 - Lot Number 07BK2302

Catalog Number 777426 - Lot Number 07GK0081.

REASON: Packaged with wrong guidewire.

MANUFACTURER/RECALLING FIRM: Bard Glens Falls Operation, Queensbury, NY.

RECALLED BY: C. R. Bard, Inc. Covington, GA

DISTRIBUTION: Nationwide.

QUANTITY: 150 Units.

PRODUCT AND CODE: Diamedix/immunosimplicity brand of anti-Sm/RNP Enzyme Immunoassay Test Kit, For in Vitro Diagnostic Use, 96 test kit, catalog No. 720-270.

CODES: 50700Z, Expiration date of April 2001.

REASON: Positive control failed to recover within its assigned range.

MANUFACTURER/RECALLING FIRM: Diamedix Corp, Miami, FL.

DISTRIBUTION: NY and IL.

QUANTITY: 13.

PRODUCT AND CODE: Sunsoft Additions contact lenses, Sunsoft Multiples Toric, and Sunsoft Sphere Multiples.

CODES: Various lot numbers and sequences.

REASON: Contact lenses may vary from the labeled power by as much as 0.75 diopters.

MANUFACTURER/RECALLING FIRM: Sunsoft Corp., Albuquerque, NM.

DISTRIBUTION: Nationwide and Canada, Denmark, France, Germany, Netherlands, Norway, Portugal, Sweden, and Turkey.

QUANTITY: 892 lenses.

PRODUCT AND CODE: Premier Human Lyme EIA, an in-vitro diagnostic test kit. The kits should contain 2 microplates containing

96 test wells per plate. Kits are packaged and sold individually.

CODES: Lot #696032.018.

REASON: The kits are packaged with less test wells than labeled.

MANUFACTURER/RECALLING FIRM: Meridian BioScience, Inc., Cincinnati, OH.

DISTRIBUTION: CT, IA, MD, MA, NJ, VA, and Belgium.

QUANTITY: 151 kits.

PRODUCT AND CODE: Premier EBV IgG ELISA, in-vitro diagnostic test kits, packaged under the Gull label.

CODES: Catalog Number: EBE100.

REASON: Microwells that are washed automatically may result in an invalid test assay.

MANUFACTURER/RECALLING FIRM: Meridian Diagnostics, Inc., Cincinnati, OH.

DISTRIBUTION: Nationwide.

QUANTITY: 946 kits.

PRODUCT AND CODE: MRO Reverse Osmosis (RO) Water Treatment System.

CODE: All MRO Hemodialysis RO Water Treatment Systems.

REASON: Defective sensor will result in a false high conductivity reading and trigger alarm.

MANUFACTURER/RECALLING FIRM: Ameriwater, Dayton, OH.

DISTRIBUTION: NY.

QUANTITY: 59 units.

WEEK ENDING SEPTEMBER 15

PRODUCT AND CODE: Sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw

Driver***Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***”.

Non-sterile product is packaged in a white Tyvek pouch labeled in part, “MacroPore Instrument***StarBurst Screw Driver***Non-

Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***”.

Labeling for the product is labeled in part, “Instructions For Use***MacroPore Craniomaxillofacial (CMF) and Neurological (Neuro)

Surgery Products***DESCRIPTION***INDICATIONS*** CONTRAINDICATIONS***WARNINGS AND PRECAUTIONS***STORAGE AND HANDLING***POSSIBLE ADVERSE EFFECTS***PROCEDURE***CLEANING AND STERILIZATION*** CAUTIONS***MACROPORE***San Diego, CA 92121***”.CODES: Lot 50489, Exp Date 5/2005

REASON: False perception of sterility on part of users.

MANUFACTURER/RECALLING FIRM: MACROPORE, INC. SAN DIEGO, CA

DISTRIBUTION: TN

QUANTITY: 62

PRODUCT AND CODE: Laser Product/Custom Gaging System; Model name and number: Custom gaging system.

REASON: The products did not comply with the warning logotype, aperture label, identification and certification label requirements.

MANUFACTURER/RECALLING FIRM: Kurt Manufacturing Company, Minneapolis, MN

DISTRIBUTION: Nationwide

QUANTITY: 5 units

PRODUCT AND CODE: Dynarad Model HF-110A Mobile X-Ray System; Codes: Model HF-110A, serial numbers 0101 through 1085

REASON: Cracks may occur in the yoke supporting the generator

MANUFACTURER/RECALLING FIRM: Dynarad Corp., Deer Park, NY.

RECALLED BY: Del Medical Imaging Corp., Franklin Park, IL

DISTRIBUTION: Nationwide, and International.

QUANTITY: 662 units

PRODUCT AND CODE: Multi-Therapy Ambulatory Infusion Pumps sold under the following labels:

a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump), 606000-40I (International),

606000-41 (Spanish), 606000-42 (Portugal), 606000-43 (France), 606000-44 (JMS), 606000-45 (Sweden), 606000-46 (Dutch) and 606000-47

(German)

b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832

CODES: All serial numbers with installed software V2.06.5 and lower, or V2.10.3 and lower (International version).

REASON: The infusion pump may overinfuse in the PCA mode of operation.

MANUFACTURER/RECALLING FIRM: Sabratek Corp. Skokie, IL.

RECALLED BY: Baxter Healthcare Corp

DISTRIBUTION: Nationwide and International

QUANTITY: 2000 – 4000 pumps

PRODUCT AND CODE: Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R (refurbished); for continuous or intermittent fluid delivery through clinically acceptable routes of administration such as intravenous, intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications; Made in SingaporeCodes: Product code 2M8151 and 2M8151R (refurbished), all units.

REASON: Damaged power cord may result in arcing and potential burning

MANUFACTURER/RECALLING FIRM: Baxter Healthcare PTE Ltd. Singapore, SN

RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division Round Lake, IL

DISTRIBUTION: Nationwide

QUANTITY: 80,000 pumps

PRODUCT AND CODE: Medela BiliBed Phototherapy Lamp, Model 0383009; used for the treatment of newborns with neonatal jaundice (hyperbilirubinemia); Codes:Models 0383009, all serial numbers included in the ranges of 970933 through 972184 and 1000569 through 1004473

REASON: Failure of the internal housing fan allows temperature to rise around infant.

MANUFACTURER/RECALLING FIRM: Medela A.G. CH-6340 Baar, SZ

RECALLED BY: Medela, Inc. McHenry, IL

DISTRIBUTION: Nationwide, Canada and Mexico.

QUANTITY: 575 lamps

PRODUCT AND CODE: FreshLook (phemfilcon A) Toric for Astigmatism Soft Contact Lenses with Handling Tint; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box. Codes: Lot 127945, expiration 2003-08

REASON: Mislabeled for corrective power, cylinder & axis