MAY
2001
WEEK ENDING MAY 4
PRODUCT: Infant Umbilical Clamp with Security Transponder Device.
CODES: None.
MANUFACTURER: Prosec Protection Systems, Inc., Lakewood,
NJ.
DISTRIBUTION: Nationwide.
QUANTITY: 4395 clamps.
REASON: Device to be adulterated in that the device
sometimes slips off and may lead to infection (skin and bacteria) and blood
loss.
PRODUCT: Midas Rex MRIV Motor System Catalog #MRIVMO
CODES: 9500 to 9523, 96064-2, 962012, 2259.
MANUFACTURER: Midas Rex, Fort Worth, TX.
DISTRIBUTION: Nationwide and Japan, Germany, Israel,
Norway, and Switzerland.
QUANTITY: 27
REASON: The motor overheats when operating within the
active MRI field.
PRODUCT: Res-Q Micron Automated Implantable cardioverter
a)
Model No. 101-05.
b)
Model No. 101-09.
c)
Model No. 101-10.
CODE: All serial numbers
MANUFACTURER: Sulzer Intermedics Inc. , Angleton, TX
RECALLED BY: Guidant Corporation, Cardiac Rhythm
Management, St. Paul, MN
DISTRIBUTION: Nationwide, worldwide.
QUANTITY: 2271
REASON: The unit indicates an improper end of service
message and enters into backup mode disabling defibrillation therapy.
PRODUCT: a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left
#9 35mm, Catalog No. 6088-0935-300L
b)
Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm,
Catalog No. 6088-1140-300L.
CODE: a) Lot No. S00L127; b) Lot No. S00L128.
MANUFACTURER: Howmedica Osteonics Corporation, Allendale,
N.J
DISTRIBUTION: Maryland
QUANTITY: 6 units -- 3 units of S00L127 and 3 units of
S00L128
REASON: The Osteonics Omnifit
Cemented Long Stem Femoral Hip Component - Left #9 35mm was labeled as the
Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm,
and the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11
40mm was labeled as The Osteonics Omnifit Cemented Long Stem Femoral Hip
Component - Left #9 35mm.
WEEK ENDING MAY 11
PRODUCT: ISS 2001 X-Ray Imaging System
CODE: ISS 2001 X-Ray Imaging
Systems.
MANUFACTURER: Fischer Imaging
Corporation,Denver, Colorado.
DISTRIBUTION: Nationwide.
QUANTITY: 27 units.
REASON: The systems fail to
conform to design specifications relating to the emission of electronic product
radiation.
PRODUCT: GE OEC Laser Aimer
CODE: Case Number: I1-1888.
MANUFACTURER: GE OEC Medical Systems,
UT.
DISTRIBUTION: Worldwide.
QUANTITY: 1699 units. (1452 units in
the United States)
REASON: The laser aimer became
disengaged from the image intensifier.
PRODUCT: MobileArt Mobile X-Ray System
CODE: Model MUX-100.
MANUFACTURER: Shimadzu, Kyoto, Japan.
RECALLED BY: Shimadzu, Torrance, CA
DISTRIBUTION: Nationwide.
QUANTITY: 27 units U.S. distributed.
REASON: A failure of a
semi-conductor module in the motor drive could result in the out of control
movement of the system and the emergency off button may not be effective in
removing power to the motorized drive.
PRODUCT: MobileArt Mobile X-ray System
CODE: Model MUX-100.
MANUFACTURER: Shimadzu, Kyoto, Japan.
RECALLED BY: Shimadzu, Torrance, CA
DISTRIBUTION: Nationwide.
QUANTITY: 21 units U.S. Distributed,
2 units in Inventory
REASON: A bolt securing a chain
inside the third section of the telescoping arm could come out resulting in the
unit not being able to be positioned for clinical use.
PRODUCT: Laparoscopic Clip Applier
CODE: Lot 00M150.
MANUFACTURER: Applied Medical Resources,
Laguna Hills, CA.
DISTRIBUTION: Nationwide.
QUANTITY: 87
REASON: The handle maynot allow
proper engagement of the clip applier cartridge, rendering the unit unusable.
PRODUCT: GE Senographe 2000D Mammographic X-Ray System.
Model Number 2228448
CODE: All serial numbers.
MANUFACTURER: GE Medical Systems Europe,
Buc Cedex, France.
RECALLED BY: GE Medical Systems,
Waukesha, WI
DISTRIBUTION: Worldwide.
QUANTITY: 30 units in U.S.; 33 units
in Foreign distribution.
REASON: The spot compression
paddle extended beyond the detector front by more than one percent of the
source to image distance.
PRODUCT: a) Sarns flexible aortic
arch cannula 8.00 mm (24 Fr) OD with
3/8îconnector
b) Sarns high flow aortic
arch cannula with suture flange and
luer port, 6.5 mm (20 Fr) OD with 3/8î
connector
c) Sarns 6.5 mm aortic arch
cannula with 3/8î connector
d) Sarns 24 Fr flexible
arterial cannula 8.5î, NW-soft, cm
markings, 3/8î connector with vented cap and luer port
e) Sarns 24 Fr
wire-reinforced flex aortic arch 3/8î connector with luer port
CODE:
a) Catalog No. 4335, Lot
Nos. W50743 and 236511;
b) Catalog No. 15495, Lot
Nos. 236148, 238279 and 241991;
c) Catalog No. 4448, Lot No.
W507618;
d) Catalog No. 144928, Lot
Nos. W507538 and 236153;
e) Catalog No. 14492368, Lot
No. W507617.
MANUFACTURER: Terumo Cardiovascular
Systems, Inc., Ann Arbor, MI.
DISTRIBUTION: Nationwide and Canada,
Germany, Hong Kong, Japan and Saudi Arabia.
QUANTITY: 5820.
REASON: A crack in the connector
near the joint between the connector and the cannula tube.
PRODUCT: a) King Systems brand
Jackson-Rees Modification Breathing Ciruits.
b) King Systems brand Mapleson D Breathing Circuit as follows: Ped F2
Pediatric Anesthesia Breathing Circuit Norman Elbow, individually packed
[VETERINARY DEVICE]: Anesco brand
Mapleson C Breathing Circuits.
CODE:
A. Ref # 2-60775; Lots I2CN2, I2EH6, I2I15, I2LL3 and I2NX0
B. Ref
# 370; lots I27U1, I2H13, I2JS4 and I2NN0
C. Ref
# 3700; lots I28Z3, I2DM0 and I2JY6
D. Ref
# 3701; lots I2757, I29U8, I2AV3, I2DV0, I2GG3, I2J64 and I2MB2
E. Ref
# 3702; lot I2F31
F. Ref
# 3703-375; lots I28M3, I2CD1, I2G40, I2MB3 and I2MB3
G. Ref
# 37072-WSLN; lot I2GG4
H. Ref
# 37237; lot I2JH1
I. Ref
# 3731-366WS; lots I2BK5, I2DC5, I2F32, I2IF4 and I2MM3
J. Ref
# 374; lots I2DC6, I2EJ4, I2GT4, I2H61, I2IF5 and I2K79
K. Ref
# 374Z; lots I2EQ7, I2F33, I2GG6, I2IF6 and I2L94
L. Ref
# 3741; lots I2758, I2847, I2AV4, I2EJ5, I2HP8, I2IS8, I2K80, I2MX2 and I2DM1
M. Ref
# 3741-WSNZ; lots I28M4, I2D11 and I2MX3
N. Ref
# 3742; lots I2A61, I2J65, I2KV3, I2PG7, 128M5 and 12MX4
O. Ref
# 3743, lots I2IS9 and I2MX5
P. Ref
# 3743-321WS; lots I28Z4, I2C03, I2GG5 and I2J66
Q. Ref
# 3743-6031; lot I2557
R. Ref
# 3743-WSN; lots I2CD2 and I2G41
S. Ref
# 3745; lot I2MX6
T. Ref
# 3771; lots I2D12, I2EJ6, I2GG7, I2KV4, I2N95 and I2DM2
U. Ref
# 3771-WSN; lots I2558, I26I6, I27I4, I27U2, I2B33, I2CP7, I2E60 and I2FV6
V. Ref
# 3771Z; lot I2HI4
W. Ref
# 3772; lot I2MB4
X. Ref
# 3772-WSN; lots I2559, I26I7, I2B34, I2CP8, I2E61, I2FV7, I2IF7, I2JS5 and
I2L95
Y. Ref
# 3773-WSN; lot I28M6
Z. Ref
# 3775; lots I2DM3 and I2LN6
AA. Ref
# 3775-WS; lot I2848
AB. Ref
# 6072442P; lots I2FH3 and I2IH4
AC. Ref
# 60740; lots I29V7, I2AW5, I2CE1, I2EL1, I2GI0, I2JH6, I2LP4 and I2PH0
AD. Ref
# 60742; lots I26U5, I2906, I29V8, I2AW6, I2GI1, I2MY8 and I2PS0
AE. Ref
# 60743; lots I28N2, I2AW7, I2DD7, I2F39, I2HF3, I2JH7 and I2MD1
AF. Ref
# 60771; lots I2649, I2E69 and I2G12
AG. Ref
# 60772; lots I2IH5 and I2MD2
AH. Ref
# 60773; lots I2767, I29J5, I2F93, I2JH8, I2LA1 and I2MD3
AI. Ref
# 61740; lot I2KA0
AJ. Ref
# 61743; lots I2CQ9, I2EL2 and I2JS9
AK. Ref
# 61750; lots I26J3, I27J9, I29V9, I2BC0, I2CR0, I2EL3, I2GW6, I2IH6, I2JT0,
I2LA3 and I2Q33
AL. Ref
# 61772; lots I26U6, I27K0, I2BL1 and I2HF4
AM. Ref
# 61773; lots I27K1, I2B42, I2E70, I2FW6, I2HF5, I2JT1 and I2LA4
AN. Ref # FGL3740; lots I2DP6 and I2G91
II. King
Systems brand Mapleson D breathing circuits, as follows:
A. Ref
# 4710-101; lot I2GT5
B. Ref
# 4740; lots I2B39 and I2JH2
C. Ref
# 4741; lots I29E1 and I2CQ3
D. Ref
# 4760; lot I28M8
E. Ref
# 4762; lots I28Z9, I2BL0, I2H64 and I2N99
AK. Ref
# 61750; lots I26J3, I27J9, I29V9, I2BC0, I2CR0, I2EL3, I2GW6, I2IH6, I2JT0,
I2LA3 and I2Q33
AL. Ref
# 61772; lots I26U6, I27K0, I2BL1 and I2HF4
AM. Ref
# 61773; lots I27K1, I2B42, I2E70, I2FW6, I2HF5, I2JT1 and I2LA4
AN. Ref # FGL3740; lots I2DP6 and I2G91
II. King
Systems brand Mapleson D breathing circuits, as follows:
A. Ref
# 4710-101; lot I2GT5
B. Ref
# 4740; lots I2B39 and I2JH2
C. Ref
# 4741; lots I29E1 and I2CQ3
D. Ref
# 4760; lot I28M8
E. Ref
# 4762; lots I28Z9, I2BL0, I2H64 and I2N99
III. Ped
F2 Pediatric Anesthesia Breathing Circuit, Ref # F90542; lot I2A06
IV. Norman
elbow, individually packaged, Ref # 838-052-100P; lot I28Q1
V. [VETERINARY
DEVICE]: Anesco brand Mapleson C
breathing circuits, Ref # A1003; lot I2H29.
ANESCO, P.O. Box 492, Georgetown, Kentucky.
MANUFACTURER: King Systems Corporation,
Noblesville, IN.
DISTRIBUTION: Nationwide, and Canada,
Japan and Mexico.
QUANTITY: 21,680.
REASON: There is a possible
obstruction of the fresh gas inlet of the elbow.
PRODUCT: Access Rubella IgG Reagent Packs
CODE: Part No. 34430, Lot
Number/Serial Number 090240.
MANUFACTURER: Beckman Coulter, Inc.,
Brea, CA.
DISTRIBUTION: Nationwide and Australia, Italy,
Mexic, Switzerland, England, France, Germany, Ireland, South Africa, Japan,
Hong Kong, Taiwan, Sweden, Netherlands, Germany, Republic of Signapore, Puerto
Rico and Spain.
QUANTITY: 2024.
REASON: Adulterated in under
filled reagent wells may produce false negative or false positive test results.
PRODUCT: AncureÆ EndograftÆ System
CODE: Model Numbers:
102241712-02, 102241812-02, 102261213-02, 102261313-02, 102261413-02, 102261513-02, 102261613-02, 102261713-02, 102261813-02, 102262113-02, 102262213-02, 102262413-02
204201210-02, 204201310-02, 204201410-02,
204201610-02, 204221211-02, 204221311-02, 204221411-02, 204221511-02,
204221611-02, 204221711-02, 204241212-02, 204241312-02, 204241412-02
204241512-02, 204241612-02, 204241712-02,
204241812-02, 204241912-02, 204261213-02, 204261313-02, 204261413-02,
204261513-02, 204261613-02, 204261713-02, 204261813-02, 204261913-02,
3052209-02, 3052409-02, 3052411-02
13415, 13417, 13422, 13423, 13424, 13425, 13426,
13427, 13428, 13429, 13430, 13431, 13432, 13433, 13434, 13435, 13436, 13437,
13438, 13439, 13440, 13441, 13442, 13443, 13444, 13445, 13454, 13455, 13456,
13462, 13463, 13464, 13465, 13466, 13467, 13470, 13471, 13472, 13473, 13474
13476, 15331, 16023, 16035, 16036, 16037, 16038,
16043, 16045, 16046 Date of Manufacture: November 8, 1999 to March 16, 2001.
MANUFACTURER: Guidant Corporation,
Endovascular Solutions, Menlo Park, CA
DISTRIBUTION: Worldwide and nationwide.
QUANTITY: 1797.
REASON: Problems experienced
during the deployment of the graft and the retrieval of the catheter.
PRODUCT: a) Upgradable Achieva Ventilator Models: Achieva Achieva X, Achieva PS, Achieva PSx
b) New Achieva Plus Ventilator Models: Achieva Achieva PS, Achieva PSO2
CODE: The new and upgraded
Achieva Plus Ventilators have the following part and model numbers (The + in
the model number indicates Achieva Plus):
Part Number Product
Model
Y-102243-00A Y-ACHPS02+E
Y-102243-02A Y-ACHPS02+F
Y-102243-03A Y-ACHPS02+G
Y-102243-04A Y-ACHPS02+I
Y-102243-05A Y-ACHPS02+J
Y-102243-06A Y-ACHPS02+S
Y-102243-07A Y-ACHPS02+U
Y-102243-22A Y-ACHPS+F
Y-102243-23A Y-ACHPS+G
Y-102243-24A Y-ACHPS+I
Y-102243-25A Y-ACHPS+J
Y-102243-27A Y-ACHPS+U
Y-102243-40A Y-ACH+E
Y-102243-42A Y-ACH+F
Y-102243-43A Y-ACH+G
Y-102243-44A Y-ACH+I
Y-102243-45A Y-ACH+J
Y-102243-46A Y-ACH+S
Y-102243-47A Y-ACH+U
Y-102901-00 ASSY,
ACH LOGIC+FA BASE
Y-102903-00 ASSY,ACH.LOG,+FA,PSO2
Y-REFACHPSO2+E REFURB
ACHIEVA+PSO2 ENG N.AM
MANUFACTURER: Nellcor Puritan Bennett,
Inc.,/Mallinckrodt, Inc.,
DISTRIBUTION: Nationwide and Canada,
Europe, Latin America and Asia.
QUANTITY: 437.
REASON: The devices may produce
over-pressure conditions to the lungs that could place the patient at risk.
PRODUCT: Custom Gown Pack, Sterile
CODE: Pack#120013 Lot: 93079.
MANUFACTURER: Sterile Recoveries, Inc.,
Long Beach, CA.
DISTRIBUTION: Los Angeles, CA.
QUANTITY: 1 device.
REASON: Device adulterated in that
the custom gown pack is possibly non-sterile due to the lack of records showing
that the unit received its sterilization cycle.
PRODUCT: 2.0 mm Universal Drill Guide
CODE: Product number 323.201 Lot
number 4043697
MANUFACTURER: SYNTHES (USA) PAOLI, PA
DISTRIBUTION: AZ, CA, GA, MI, NC, NY,
OH, PA, TN, and UT. Switzerland.
QUANTITY: 19 units
REASON: The device consists of a
1.5 mm drill guide on one end and a 2.0 mm drill guide on the other end. The 1.5 mm end has been etched as 2.0 mm and
the 2.0 mm end has been etched as 1.5 mm.
PRODUCT: MedComp 14F Ash Split Cath Long Term, Duo-Flow
400XL, and Duo-Split Cath Short Term Hemodialysi or Apheresis Catheters
CODE: Catalog Numbers: ASPC24
(14F x 24 cm Ash Split Cath), ASPC28 (14F x 28cm Ash Split Cath), ASPC28I (14F
x 28cm Ash Split w/Introducer), ASPC32 (14F x 32cm Ash Split Cath Set), ASPC32I
(14F x 32cm Ash Split w/Introducer), ASPC32MP (14F x 32cm Ash Split w/MP4),
ASPC36 (14F x 36 cm Ash Split Cath Set), ASPC55 (14F x 558cm Ash Split Cath),
DFXL146CT (14F x 15cm Duo-Flow 400XL Cath), DFXL146MTB (14F x 15cm Duo-Flow
400XL Cath), DFXL146IJS (14F x 15cm Duo-Flow 400XL IJ), DFXL148 (14F x 20cm
Duo-Flow XL Tray),
DFXL148CT (14F x 20cm Duo-Flow 400XL Cath),
DXFL148MT (14F x 20cm Duo-Flow 400XL Set), DXFL148MTB (14F x 20cm Duo-Flow
400XL Set), DFXL149CT (14F x 24cm Duo-Flow 400XL Cath), DSP128M (12.5F x 20cm
Duo-Split), Tray #552 (14F x 28cm Ash Split Cath), Tray #553 (14F x 32 cm Ash
Split Cath), and Tray #594 (14F x 36cm Ash Split Cath Set).
MANUFACTURER: Medical Components, Inc.
Harleysville, PA.
DISTRIBUTION: The following countries
received product Canada and South Korea.
The following are government/military accounts: CALM VA in Dallas and
Houston, TX; Defense Fin, San Antonio, TX; DFAS, Fort Sam Houston, TX; Fort
Atkinson Memorial, Fort Atkinson, WI; VA, Miami, Fl; NNMC, Bethesda, Md; Naval
Med Ctr, Portsmouth, VA; Naval Med Ctr, San Diego, CA; and the VA Hospitals in
San Juan, PR; Austin, TX; Philadelphia, PA; Cincinnati, OH; Indianapolis, IN;
Minneapolis, MN; Asheville, NC; Loma Linda, CA; Los
Angeles, CA; San Diego, CA; Long Beach, CA; Salem,
VA; Iowa City, IA; St. Louis, MO; Tampa, Fl; Durham, NC; West Haven, CT; and
Gainesville, FL.
QUANTITY: 5930 units.
REASON: Certain Ash Split
Catheters had leaked through the pinch/line clamp immediately following
insertion. The recalling firm confirmed that the clamp may not occlude the
extensions for the three product lines.
PRODUCT: ADVIA: Centaur Analyzer
CODE: The following serial
numbers are affected: 1638 - 1641; 1644 - 1743; 1760 - 2035; and 2501 - 2584.
MANUFACTURER: BAYER CORP. OBERLIN, OH
The manufacturer of the defective valve component is: Parker Hannifin
Corporation, Fairfield, NJ 07006.
DISTRIBUTION: Nationwide, including the
following U.S. VA Medical centers: Brooklyn, NY; Tucson, AZ; and Alexandrea,
LA. The device was also shipped to the
following foreign countries: S. Africa,
Australia, Belgium, Brazil, Canada, Denmark, France, Germany, Hong Kong, India,
Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal,
Puerto Rico, Spain, Swedeb, Switzerland, Taiwan, Turkey, and United Kingdom.
QUANTITY: 359 units (192 domestic,
167 foreign).
REASON: A defective 3-way valve,
which is used only during the Daily Cleaning Procedure, may cause the
hypochlorite cleaning solution to flow into the system water reservoir. As a result, there is a potential for
inaccurate test results.
PRODUCT: Flexilab Versions 5.23 and 5.3 with callback
System Versions 3.0.50.1
CODE: Versions 3.0.50.1.
MANUFACTURER: Sunquest Information
Systems, Inc., Tucson, AZ.
DISTRIBUTION: Nationwide, and Ireland,
United Kingdom, Saudi Arabia, Denmark.
QUANTITY: 80.
REASON: Device adulterated in that
inappropriate output when patientís age is unknown may occur.
PRODUCT: LADARVision Excimer System and LADARVision 4000
Excimer Laser System
a) Product No. 6509-0078;
b) Product No. 6509-4000;
c) Product No. 6509-0285;
d) Product No. 6509-0126;
e) Product No. 6509-0131;
f) Product No. 6509-0137;
g) Product No. 6509-0336;
CODE: 10, 12, 14, 17, 1018,
1019, 21, 22, 23, 1025, 26, 1027, 28, 30 to 34, 1035 to 1037, 38 to 42, 44 to
49, 1051 to 1060, 1062 to 1064, 1066, 1068 to 1079, 1081, 1085 to 1111, 1113 to
1129, 1131 to 1134, 1136 to 1144, 1147 to 1150, 1152, 1154, 1156 to 1158, 1160,
1163, 1168, 1169, 1190, 1192 to
1195, 1199, 1200.
MANUFACTURER: Autonomous Technologies
Corp., Orlando, FL
DISTRIBUTION: Nationwide, and Canada,
Italy, United Kingdom, Spain, Australia, Greece, Thailand, Phillipines.
QUANTITY: 136 units.
REASON: Devices adulterated in
that unanticipated laser pulses reaching the cornea will cause ablation of the
corneal surface, which could result in a central corneal defect of about 1mm in
diameter.
PRODUCT: Infant Umbilical Clamp with Security Transponder Device.
CODE: None.
MANUFACTURER: Prosec Protection Systems, Inc., Lakewood,
NJ.
DISTRIBUTION: Nationwide.
QUANTITY: 4395 clamps.
REASON: Device sometimes slips off and may lead to
infection (skin and bacteria) and blood loss.
PRODUCT: Midas Rex MRIV Motor System Catalog #MRIVMO
CODES: 9500 to 9523, 96064-2, 962012, 2259.
MANUFACTURER: Midas Rex, Fort Worth, TX.
DISTRIBUTION: Nationwide and Japan, Germany, Israel,
Norway, and Switzerland.
QUANTITY: 27
REASON: The motor overheats when operating within the
active MRI field.
PRODUCT: Res-Q Micron Automated Implantable cardioverter.
a)
Model No. 101-05; b) Model No. 101-09; c) Model No. 101-10
CODES: All serial numbers.
MANUFACTURER: Sulzer Intermedics Inc., Angleton, TX.
RECALLED BY: Guidant Corporation, Cardiac Rhythm
Management, St. Paul, MN
DISTRIBUTION: Nationwide, worldwide.
QUANTITY: 2271.
REASON: The unit indicates an improper end of service
message and enters into backup mode disabling defibrillation therapy.
PRODUCT: a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left
#9 35mm, Catalog No. 6088-0935-300L
b)
Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm,
Catalog No. 6088-1140-300L.
CODE: a) Lot No. S00L127; b) Lot No. S00L128.
MANUFACTURER: Howmedica Osteonics Corporation, Allendale,
N.J.
DISTRIBUTION: Maryland.
QUANTITY: 6 units -- 3 units of S00L127 and 3 units of S00L128.
REASON: The Osteonics Omnifit Cemented Long Stem Femoral
Hip Component - Left #9 35mm was labeled as the Osteonics Omnifit Cemented Long
Stem Femoral Hip Component - Left # 11 40mm, and the Osteonics Omnifit Cemented
Long Stem Femoral Hip Component - Left # 11 40mm was labeled as the Osteonics
Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm.
PRODUCT: Optetrak Total Knee Augmentation Blocks
CODE: Part Description Catalog Number
5mm
Tibial Augmentation 1/3 Block Sz.1 204-41-05
8mm
Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.1 204-41-89
5mm
Tibial Augmentation 1/3 Block Sz.2 204-42-05
8mm
Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL,
RM
Tibial Augmentation 1/3 Block Sz.2 204-42-89
5mm
Tibial Augmentation 1/3 Block Sz.3 204-43-05
8mm
Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL,
RM
Tibial Augmentation 1/3 Block Sz.3 204-43-89
5mm
Tibial Augmentation 1/3 Block Sz.4 204-44-05
8mm
Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.4 204-44-89
5mm
Tibial Augmentation 1/3 Block Sz.5 204-45-05
8mm
Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.5 204-45-89
1/2
Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05
1/2
Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08
5mm
Tibial Augmentation 1/2 Block Sz.1 204-61-05
8mm
Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz.1 204-61-89
5mm
Tibial Augmentation 1/2 Block Sz.2 204-62-05
8mm
Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz.2 204-62-89
5mm
Tibial Augmentation 1/2 Block Sz 3 204-63-05
8mm
Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz 3 204-63-89
5mm
Tibial Augmentation 1/2 Block Sz 4 204-64-05
8mm
Tibial Augmentation 1/2 Block Sz 4 204-64-08
11mm
RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88
11mm
RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89
5mm
Tibial Augmentation 1/2 Block Sz 5 204-65-05
8mm
Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz 5 204-65-89
Full
Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07
Full
Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07
Full
Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13
Full
Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20
Full
Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07
Full
Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13
Full
Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20
Full
Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07
Distal
5mm Femoral Aug, Sz. 1 208-05-01
Distal
5mm Femoral Aug, Sz. 2 208-05-02
Distal
5mm Femoral Aug, Sz. 3 208-05-03
Distal
5mm Femoral Aug, Sz. 4 208-05-04
Distal
5mm Femoral Aug, Sz. 5 208-05-05
Distal
10mm Femoral Aug. Sz. 1 208-06-01
Distal
10mm Femoral Aug, Sz. 2 208-06-02
Distal
10mm Femoral Aug, Sz. 3 208-06-03
Distal
10mm Femoral Aug, Sz. 4 208-06-04
Distal
10mm Femoral Aug, Sz. 5 208-06-05
Posterior
5mm Femoral Aug, Sz. 1 208-07-01
Posterior
5mm Femoral Aug, Sz. 2 208-07-02
Posterior
5mm Femoral Aug, Sz. 3 208-07-03
Posterior
5mm Femoral Aug, Sz. 4 208-07-04
Posterior
5mm Femoral Aug, Sz. 5 208-07-05
Posterior
10mm Femoral Aug, Sz. 1 208-08-01
Posterior
10mm Femoral Aug, Sz. 2 208-08-02
Posterior
10mm Femoral Aug, Sz. 3 208-08-03
Posterior
10mm Femoral Aug, Sz. 4 208-08-04
Posterior
10mm Femoral Aug, Sz. 5 208-08-05
5mm
Tibial Augmentation 1/3 Block Sz.1 204-41-05
8mm
Tibial Augmentation 1/3 Block Sz.1 204-41-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.1 204-41-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.1 204-41-89
5mm
Tibial Augmentation 1/3 Block Sz.2 204-42-05
8mm
Tibial Augmentation 1/3 Block Sz.2 204-42-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.2 204-42-88 11mm LL,
RM
Tibial Augmentation 1/3 Block Sz.2 204-42-89
5mm
Tibial Augmentation 1/3 Block Sz.3 204-43-
8mm
Tibial Augmentation 1/3 Block Sz.3 204-43-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.3 204-43-88 11mm LL,
RM
Tibial Augmentation 1/3 Block Sz.3 204-43-89
5mm
Tibial Augmentation 1/3 Block Sz.4 204-44-05
8mm
Tibial Augmentation 1/3 Block Sz.4 204-44-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.4 204-44-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.4 204-44-89
5mm
Tibial Augmentation 1/3 Block Sz.5 204-45-
8mm
Tibial Augmentation 1/3 Block Sz.5 204-45-08 11mm RL,
LM
Tibial Augmentation 1/3 Block Sz.5 204-45-88 11mm RM,
LL
Tibial Augmentation 1/3 Block Sz.5 204-45-89
1/2
Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05
1/2
Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08
5mm
Tibial Augmentation 1/2 Block Sz.1 204-61-05
8mm
Tibial Augmentation 1/2 Block Sz.1 204-61-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz.1 204-61-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz.1 204-61-89
5mm
Tibial Augmentation 1/2 Block Sz.2 204-62-05
8mm
Tibial Augmentation 1/2 Block Sz.2 204-62-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz.2 204-62-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz.2 204-62-89
5mm
Tibial Augmentation 1/2 Block Sz 3 204-63-05
8mm
Tibial Augmentation 1/2 Block Sz 3 204-63-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz 3 204-63-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz 3 204-63-89
5mm
Tibial Augmentation 1/2 Block Sz 4 204-64-05
8mm
Tibial Augmentation 1/2 Block Sz 4 204-64-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz 4 204-64-88 11mm RM,
LL Tibial
Augmentation 1/2 Block Sz 4 204-64-89
5mm
Tibial Augmentation 1/2 Block Sz 5 204-65-05
8mm
Tibial Augmentation 1/2 Block Sz 5 204-65-08 11mm RL,
LM
Tibial Augmentation 1/2 Block Sz 5 204-65-88 11mm RM,
LL
Tibial Augmentation 1/2 Block Sz 5 204-65-89
Full
Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07
Full
Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07
Full
Wedge Tibial Augmentation, Size 3 X 20ƒ 204-82-13
Full
Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20
Full
Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07
Full
Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13
Full
Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20
Full
Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07
Distal
5mm Femoral Aug, Sz. 1 208-05-01
Distal
5mm Femoral Aug, Sz. 2 208-05-02
Distal
5mm Femoral Aug, Sz. 3 208-05-03
Distal
5mm Femoral Aug, Sz. 4 208-05-04
Distal
5mm Femoral Aug, Sz. 5 208-05-05
Distal
10mm Femoral Aug. Sz. 1 208-06-01
Distal
10mm Femoral Aug, Sz. 2 208-06-02
Distal
10mm Femoral Aug, Sz. 3 208-06-03
Distal
10mm Femoral Aug, Sz. 4 208-06-04
Distal
10mm Femoral Aug, Sz. 5 208-06-05
Posterior
5mm Femoral Aug, Sz. 1 208-07-01
Posterior
5mm Femoral Aug, Sz. 2 208-07-02
Posterior
5mm Femoral Aug, Sz. 3 208-07-03
Posterior
5mm Femoral Aug, Sz. 4 208-07-04
Posterior
5mm Femoral Aug, Sz. 5 208-07-05
Posterior
10mm Femoral Aug, Sz. 1 208-08-01
Posterior
10mm Femoral Aug, Sz. 2 208-08-02
Posterior 10mm Femoral Aug, Sz. 3 208-08-03
Posterior 10mm Femoral Aug, Sz. 4 208-08-04
Posterior 10mm Femoral Aug, Sz. 5 208-08-05.
MANUFACTURER: EXACTECH, INC. 2320 N.W.
66TH CT. Gainesville, FL.
DISTRIBUTION: Nationwide.
QUANTITY: 1440.
REASON: Sterility barrier failure
PRODUCT: OncoSeed Iodine-125 Seeds; a welded titanium capsule
containing Iodine-125 adsorbed onto a silver rod; Medi-Physics, Inc., Arlington
Heights, IL 60004 U.S.A.
CODE: 6711
MANUFACTURER: Medi-Physics, Inc. dba
Nycomed Amersham Imaging, Arlington Heights, IL.
DISTRIBUTION: Ottawa Regional Cancer
Centre, Ottawa, Canada.
QUANTITY: 165 seeds.
REASON: Seeds have a higher
radioactivity than stated on the label
PRODUCT: Efica CC (Dynamic Air Therapy Unit). Recall
#Z-560-1.
CODE: Serial Numbers
*LA700023-LA708141 (*not all inclusive) Manufactured 7/94 - 5/98
MANUFACTURER: Hill-Rom, Inc.,
Charleston, SC.
DISTRIBUTION: Nationwide and to Brazil,
Egypt, Japan, Malaysia, Mexico, Poland, Taiwan and United Arabia Emerance. There was also government distribution.
QUANTITY: 2450 units
REASON: Device batteries were
alleged to have given off a strong odor.
PRODUCT: a) NexGen Knee Threaded Fixation Pin; b) NexGen
Knee Threaded Fixation Pin
CODE: a) Lot No. 71350300, Catalog No.
00-5978-013-00; b) Lot No. 71915000,
Catalog No. 00-5978-013-00.
MANUFACTURER: Zimmer, Inc., Warsaw, IN.
DISTRIBUTION: United States, Australia,
Belgium, Canada Germany, Italy, Japan and the United Kingdom.
QUANTITY: 708
REASON: The hex end of the pin
will not assemble with the driver to secure the Micro-Mill femoral mounting base
instrumentation to the surgical site.
PRODUCT: Thermo Labsystemís DSX Automated System.
CODE: a) Model No. 61500; b) Model No. 65200; c) Model No. 65210; d) Model No. 65300; e) Model No. 65400; f) Model No. 65410; and
g) Model No.
65500.
MANUFACTURER: DYNEX TECHNOLOGIES (THERMO
LABSYSTEMS), Chantilly, VA.
DISTRIBUTION: Nationwide, and Spain,
Hong Kong, United Kingdom, Australia, Korea, and Italy.
QUANTITY: 73.
REASON: Incorrect sample volume
may be dispensed and therefore produce erroneous test results. In addition, an Electro Magnetic
incompatibility in the instrument may cause instrument to report an error and
lock-up.
PRODUCT: MedComp 14F Ash Split Cath Long Term, Duo-Flow
400XL, and Duo-Split Cath Short Term Hemodialysi or Apheresis Catheters.
CODE: Catalog Numbers:
ASPC24 (14F x 24 cm Ash Split Cath),
ASPC28 (14F x 28cm Ash Split Cath),
ASPC28I (14F x 28cm Ash Split w/Introducer),
ASPC32 (14F x 32cm Ash Split Cath Set),
ASPC32I (14F x 32cm Ash Split w/Introducer),
ASPC32MP (14F x 32cm Ash Split w/MP4),
ASPC36 (14F x 36 cm Ash Split Cath Set),
ASPC55 (14F x 558cm Ash Split Cath),
DFXL146CT (14F x 15cm Duo-Flow 400XL Cath),
DFXL146MTB (14F x 15cm Duo-Flow 400XL Cath),
DFXL146IJS (14F x 15cm Duo-Flow 400XL IJ),
DFXL148 (14F x 20cm Duo-Flow XL Tray),
DFXL148CT (14F x 20cm Duo-Flow 400XL Cath),
DXFL148MT (14F x 20cm Duo-Flow 400XL Set),
DXFL148MTB (14F x 20cm Duo-Flow 400XL Set),
DFXL149CT (14F x 24cm Duo-Flow 400XL Cath),
DSP128M (12.5F x 20cm Duo-Split),
Tray #552 (14F x 28cm Ash Split Cath),
Tray #553 (14F x 32 cm Ash Split Cath),
Tray #594 (14F x 36cm Ash Split Cath Set).
MANUFACTURER: MEDICAL COMPONENTS, INC.,
Harleysville, PA.
DISTRIBUTION: Canada and South Korea.
The following are government/military accounts: CALM VA in Dallas and Houston,
TX; Defense Fin, San Antonio, TX; DFAS, Fort Sam Houston, TX; Fort Atkinson
Memorial, Fort Atkinson, WI; VA, Miami, Fl; NNMC, Bethesda, Md; Naval Med Ctr,
Portsmouth, VA; Naval Med Ctr, San Diego, CA; and the VA Hospitals in San Juan,
PR; Austin, TX; Philadelphia, PA; Cincinnati, OH; Indianapolis, IN;
Minneapolis, MN; Asheville, NC; Loma Linda, CA; Los Angeles, CA; San Diego, CA;
Long Beach, CA; Salem, VA; Iowa City, IA; St. Louis, MO; Tampa, Fl; Durham, NC;
West Haven, CT; and Gainesville, FL.
QUANTITY: 5930 units.
REASON: Pinch/line clamp not fully
occluding tubing when engaged.