MARCH 2001
WEEK ENDING MARCH 2
PRODUCT: Cytodrape probe cover and
drape
CODE: Lot number 0800101 Part
number AY000293.
MANUFACTURER: Cytometrics, Inc.,
Philadelphia, PA.
DISTRIBUTION: NC, AZ, TX, and
DC.
QUANTITY: 140
units.
REASON: May not have received
adequate dose of radiation to sterilize product.
PRODUCT: EScreen System, which
collectively includes the eCUP, the eREADER optical imaging technology, and the
eCUP data analysis
software, for use in drug
abuse testing.
CODE: All.
MANUFACTURER: EScreen Inc., Overland
Park, KS.
DISTRIBUTION:
Nationwide.
QUANTITY: 300
units.
REASON: Distributed without 510(k)
clearance.
PRODUCT: Giardia lamblia Antigen
Detection Microwell ELISA. Cat.#
GL-35M 96 Test.
CODE: Lot 9906226. Exp. Date March
2001.
MANUFACTURER: Alexon-Trend, Inc.,
Ramsey, MN.
DISTRIBUTION: Idaho, New Mexico and
South Dakota.
QUANTITY: 258
Kits.
REASON: Product is not labeled as
investigational use, has no 510(k) clearance.
PRODUCT: BD Syringe 3 ml with
21G1.5’’ PrecisionGlide Needle.
CODE: Lot Nos. 00C3461, 00C3462,
00C3463, 00F3461, 00G3461, and 00G3462.
Catalog #309577;
MANUFACTURER: Becton Dickinson &
Co., Franklin Lakes, NJ.
DISTRIBUTION:
Nationwide.
QUANTITY: 4,802,000
syringes.
REASON: The needle shields may
disengage from the needle.
PRODUCT: Model Eclipse TMR2000
Holmium Laser System
CODE: All.
MANUFACTURER: Eclipse Surgical
Technologies, Sunnyvale, CA.
DISTRIBUTION:
Nationwide.
QUANTITY: 246
units.
REASON: Lacked procedures for
periodic recalibration of the laser system.
PRODUCT: SpF Implantable Spinal
Fusion Stimulator and OsteoGen Surgically Implanted Bone Growth
Stimulator
a)
Model SpF XL 4/CW;
b)
Model SpF 2T/C;
c)
Model SpF 2TT/CW;
d)
Model SpF 2T/D;
e)
Model SpF 2T/DW;
f)
Model SpF 2T/F;
g)
Model SpF 2T/FW;
h)
Model SpF 2T/GW;
i)
Model SpF 2T/DLW;
j)
Model SpF 2T/GLW;
k)
Model SpF 4T/C;
l)
Model SpF 2/C;
m) Model OSTEOGEN;
n) Model OSTEOGEN-M;
o) Model OSTEOGEN/F;
p) Model SpF XL II, 2/DW;
q) Model SpF XL, 2/DM;
r) Model SpF-XL IIb, 2/DW.
CODES:
a) Ref. #101370W; b) Ref. #101332; c) Ref. #101332W; d) Ref. # 101362; e) Ref. #101362W; f) Ref. #101382; g) Ref. #101382W; h) Ref. #101392W; i) Ref.#101363W; j) Ref. #101393W; k) Ref. #101334; l) Ref. #101304; m) Ref. #101325; n) Ref. #101325M; o) Ref. #101330;
p) Ref. #101375W; q) Ref.
#101385M; r) Ref. #101385W.
MANUFACTURER: EBI, L.P., Parsippany,
NJ.
DISTRIBUTION:
Nationwide.
QUANTITY: 715
units.
REASON: The integrity of the
sterile packaging may be compromised.
PRODUCT: Screw Cap Centrifuge
Tubes
CODE: Part No.
3252.
MANUFACTURER: Hardy Diagnostics, Santa
Maria, CA.
DISTRIBUTION: NJ and CA. One VA account in Martinez,
CA.
QUANTITY: 6
cases.
REASON: Tubes break during
centrifugation at speed within the limit.
WEEK
ENDING MARCH 9
PRODUCT: Vitros ECi
Immunodiagnostic System
CODE: Serial Numbers: 30000001
thru 30001276; R3100151; R3100153; R3100154.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide, and 26 Federal
government customers (Government Contract GS-24f-124c)
QUANTITY: Domestic - 222 units;
International - 729 units.
REASON: Sample processing on the
system may cause incorrect results.
PRODUCT: ELA/Angeion Lyra
Implantable Cardioverter Defibrillators. Model No. 2020; Model No. 2021; Model
No. 2022.
CODES: Model No. 2020; Model No.
2021; Model No. 2022.
MANUFACTURER: Angeion Corporation, St.
Paul, MN.
DISTRIBUTION: Nationwide, and in Europe
and South America.
QUANTITY: 494.
REASON: The device may fail to
provide pacing or defibrillation therapy.
PRODUCT: Bioelectrical
Discharger: Model No. ZQ1; Model
No. ZQ2.
CODE: Model No. ZQ1; Model No.
ZQ2. All units distributed between
September 1 and December 1, 2000.
MANUFACTURER: Z' Strong International,
Inc., El Monte, CA.
DISTRIBUTION: Nationwide and the U.S.
Virgin Islands.
QUANTITY: 725
devices.
REASON: Inappropriate medical
claims.
PRODUCT: Vitros 250 Chemistry
Systems with Software Versions 6.x (6.0,6.01, 6.02, etc).
CODES: Catalog #8132086. Vitros 250 Chemistry System serial
numbers less than 2501494.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and
worldwide. There are 209 Federal
government accounts under government contract
#GS-24f-1243c.
QUANTITY: 1,780 - domestic; and
approx. 2,700 - international.
REASON: Test results may be
mis-reported as 0.0 for any analyte including CK-MB, acetaminophen, iron,
lithium, and salicylate.
PRODUCT: Carbamazepine (CRBM)
slides; 5x18 slides.
CODES: Lot Nos. 3904-0004-4318
through 3904-0004-4320, 3904-0004-5274 through 3004-0004-5277, 33904-0004-7709 and
3904-0004-7710, 3905-0005-7707, 3905-0005-0255 through 3905-0005-0257,
3905-0005-2161 through 3905-0005-2163, 3905-0005-4196 and 3905-0005-4197,
3905-0005-4249 through
3905-0005-4251, 3906-0006-7694 through 3906-7696;
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and worldwide,
and 16 Federal government consignees under government contract
V797P-6565A.
QUANTITY: 2,194 packs - domestic;
and 1,387 packs- international.
REASON: The CRBM slides were
labeled with wrong expiration date.
PRODUCT: Vitros ECi
Immunodiagnostic Systems: Catalog No. 8633893; Catalog No.
6801059.
CODES: Lot Nos. 30000001 thru
30001276, and R3100151 thru R3100158.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and worldwide,
and 25 Federal government accounts who purchased under government contract
GS-24f-1243c.
QUANTITY: 222 domestic and 717
International.
REASON: The DRD pump assembly is
out of specification, and could result in deliver of excess
fluid.
PRODUCT: Obturator for Mitral
Valves Model No. 1162, sizes 25mm-35mm.
CODE: All.
MANUFACTURER: Edwards Lifesciences LLC,
Irvine, CA.
DISTRIBUTION:
Nationwide.
QUANTITY: 1,520 of the bioprostheses
plus obturators.
REASON: Sizers do not match the
heart valves and the directions for use are inadequate.
PRODUCT: Ash Split Cathether Repair
Kit
CODE: Part Number ASPCRPK. All product is being recalled some
units were shipped without lot
numbers. Lots M017810 and M020880
are involved in the recall.
MANUFACTURER: Medical Components, Inc.,
Harleysville, PA.
DISTRIBUTION: Nationwide and
Hemodialyse, Brussel, Beligum.
QUANTITY: 354
kits.
REASON: No 510k clearance &
potentially not sterile.
PRODUCT: Hemo-Flow Long Term High
Flow Access Catheters
CODE: All lot numbers are being
recalled for all catheter sizes.
Size
Catalog/Model numbers:
14.5F x 24 cm
HFS24 (set) and HFT24 (tray)
14.5F x 28 cm
HFS28 and HFT28
14.5F x 32 cm
HFS32 and HFT32
14.5F x 36 cm
HFS36 and HFT36
14.5F x 55 cm
HFS55 and HFT55
MANUFACTURER: Medical Components, Inc.,
Harleysville, PA.
DISTRIBUTION: LA and
CT.
QUANTITY: 961
kits.
REASON: Marketed without 510k
clearance.
PRODUCT: Puritan-Bennett 740 and
Puritan-Bennett 760 Ventilator
CODE: Ventilators containing
safety valve assemblies that have lot numbers 9850, 9901, 9905, 0004, 0007,
0013, and 0017.
MANUFACTURER: Nellcor Puritan Bennett
Ireland, LTD., Galway, Ireland.
RECALLED
BY:
Mallinckrodt, Inc., St. Louis, MO
DISTRIBUTION: Nationwide, Canada and
Mexico.
QUANTITY: 615.
REASON: Remote probability for the
ventilator to remain in Safety Valve Open condition.
PRODUCT: AngioJet Rheolytic
Thrombectomy System Pump Set
CODE: Lot number range of 18612
to 19146.
MANUFACTURER: Possis Medical, Inc.,
Minneapolis, MN.
DISTRIBUTION: Nationwide,
worldwide.
QUANTITY: 3292
pumps.
REASON: Holes in outer sterile
packages.
PRODUCT: Nuclear Medicine Scanner,
DS Series
CODE: All Serial Numbers for
Models: DST-XL, DST-Xli, and
DSXi.
MANUFACTURER: SMV International, Cedex,
France.
RECALLED
BY:
SMV America, Twinsburg, OH
DISTRIBUTION: Nationwide and
worldwide.
QUANTITY: 191 units –
domestic.
REASON: Improper latching
mechanism may allow collimator to disengage during camera
use.
PRODUCT: Zevex Inc., EnteralEZ
Enteral Feeding Pump
CODE: Model EZ4500, 671
individually serialized units.
MANUFACTURER: ZEVEX, Inc., Salt Lake
City, UT.
DISTRIBUTION: FL, IL, MA, MN, OH, NC,
PA, RI, TX.
QUANTITY: 769
pumps.
REASON: Enteral feeding pump
delivers feeding solution at rates lower than specified.
PRODUCT: Smith & Nephew RotorC
Drill
CODE: Lot Numbers: 419348,
419349, and 419350.
MANUFACTURER: Smith & Nephew, Inc.,
Mansfield, MA.
RECALLED
BY:
Smith & Nephew, Inc., Andover, MA
DISTRIBUTION: Canada, Australia, Spain,
South Africa, Italy, UK, Netherlands, Germany and
Switzerland.
QUANTITY: 244.
REASON: Potential for drill to
puncture sterile package.
PRODUCT: Home Health Monitoring
System
CODE: All monitors distributed
prior to 07/18/200 are affected.
MANUFACTURER: AvidCare Corporation,
Milwaukee, WI.
DISTRIBUTION: New
York.
QUANTITY: 18 units in commercial
distribution and about 274 at IRB/NSR ide sites.
REASON: Lack of 510(k) clearance
for new device features.
PRODUCT: CliniCath IR Peripherally
Inserted Central Catheter, 5 French, Reorder Number
21-2575
CODE: Lot numbers 65784, 70656
and 71318.
MANUFACTURER: Medical Specialties, Inc.,
Tarpon Springs, FL.
RECALLED
BY:
Sims Deltec, Inc., St. Paul, MN
DISTRIBUTION: Alabama, Georgia,
Michigan, Texas and Wisconsin.
QUANTITY: 66 catheter
kits.
REASON: Product packages contain
the wrong size introducer.
PRODUCT: a) Bartels CMV EIA kit,
catalog #B1029-91; b) CMV IEA Antibody & Conjugate Kit, catalog
#B1029-91A
CODE: a) CMV IEA Kit:
LOT NO. EXPIRATION
DATE
0D198
01Mar01
0D289
01Mar01
0D292
01Mar01
0E160
01Mar01
0E276
16Mar01
0F171 16Mar01
0G190
16Mar01
0G160
16Mar01
b) CMV IEA Antibody &
Conjugate:
Lot 0D386, expiration
01Mar01.
MANUFACTURER: Intracel Corporation,
Issaquah, WA.
DISTRIBUTION: Nationwide, Canada and
Australia.
QUANTITY: 312
units.
REASON: Diminishing
fluorescence.
PRODUCT: Olympic Warm-Scale -
infant scale equipped with a heater that provides warmth for an infant while
being weighed.
CODE: Model Numbers 23 and 28,
Catalog Numbers 56323 and 56328.
MANUFACTURER: Olympic Medical Corp.,
Seattle, WA.
DISTRIBUTION: Nationwide, including 1
USPHS Indian Health Service hospital and 1 Air Force
hospital.
QUANTITY: 160.
REASON: Potential for tray and
warming platform to overheat.
PRODUCT: Supplemental Reference
Manuals:
a) IsoMed Constant-Flow
Infusion System, Clinical Reference Guide for Pain
Therapy.
b) IsoMed Constant-Flow
Infusion System, Catheter Access Port Procedure, Quick Reference Tool for
Intrathecal Drug Delivery.
c) IsoMed Constant-Flow
Infusion System, Clinical Reference Guide for Hepatic Arterial Infusion
Therapy.
d) IsoMed Constant-Flow
Infusion System, Catheter Access Port Procedure, Quick Reference Tool for
Hepatic Arterial Infusion for
Chemotherapy.
CODE: Product catalog
#:
182369-101/UC199901594 EN
NP3821
182507-101/UC200003706 EN
NP4163
182371-101/UC199901596 EN
NP3823
182509-101/UC200003707 EN
NP4164
MANUFACTURER: MEDTRONIC, INC.,
Neurological Division, Minneapolis, MN.
DISTRIBUTION: Nationwide and in
Australia.
QUANTITY: 91 copies of the
manuals.
REASON: Manuals contain incorrect
table for calculating time for drug to traverse catheter.
PRODUCT: StatView Receiver used
with the StatView System.
CODE: StatView receiver part #s
300-0302-01 through 300-0302-30, and 300-0305-01 through 300-0305-30, firmware
versions 3.00.11 and 3.01.00
respectively.
MANUFACTURER: Data Critical Corp.,
Bothell, WA.
DISTRIBUTION:
Nationwide.
QUANTITY: 1299
units.
REASON: Random and/or missed pages
for patient monitoring.
PRODUCT: Utah Medical Products a)
Umbilicup and b) Umbilicup II
Umbilical Cord Blood Sampling System.
CODE: a) Umbilicup Umbilical
Cord Blood Sampling System, Cat #UMB-100, All Lot Numbers, including: 182373-1,
190789-1, 191124-
1, 100150-1, 100577-1,
100578-1, 100580-1, 100581-1, 101015-1, 101446-1.
b) Umbilicup II Umbilical
Cord Blood Sampling System. Catalog #UMB-200, All Lot Numbers, including:
182374-1.
MANUFACTURER: Utah Medical Products,
Inc., Midvale, UT.
DISTRIBUTION: Nationwide and Canada,
Syria, Mexico, Japan and Italy.
QUANTITY: 5,296
units.
REASON: Sterility of the units
cannot be guaranteed.
PRODUCT: FREEHAND Electrode
Positioning Kits (EPK), Model 1111-1
CODE: Serial Numbers: 402, 409,
414, 415, 416, & 426.
MANUFACTURER: Neurocontrol Corp.
Valleyview, Ohio.
DISTRIBUTION: OH, NY, and
PA.
QUANTITY: 28
kits.
REASON: Device does not comply
with the performance standard for electrode lead wires and patient cables, 21
CFR 898.
PRODUCT: FluidSense FS-01 Infusion
Pump
CODE: S/N's: 100303 through
100836 (not inclusive)
MANUFACTURER: Fluidsense Corp.,
Newburyport, MA.
DISTRIBUTION: Lehigh Acres, FL and Fort
Myers, FL.
QUANTITY: 163.
REASON: If two microprocesors
simultaneously reboot, an alarm would not sound.
PRODUCT: IUI Tomcat Catheters
Kit
CODE: Lots: 791004, 791202, and
700302.
MANUFACTURER: Bioteque America, Inc.,
Langhorne, PA.
DISTRIBUTION: TX, PA, IL, CA, AR, GA,
NV, and UT.
QUANTITY: 2093
units.
REASON: No 510k clearance and lack
of sterility assurance.
PRODUCT: WC400 Word/Bartholin
Catheters
CODE: Lots: 381121 and
79102.
MANUFACTURER: Bioteque America, Inc.,
Langhorne, PA.
DISTRIBUTION: MN.
QUANTITY: 1408
units.
REASON: No 510k clearance and lack
of sterility assurance.
PRODUCT: The STERIS Quick Connect
Kit Booklets, for STERIS Quick Connect Kits #C1402, #C1403, and C1622 that are
used to process Pentax 30/40/30K series gastroscopes in the STERIS SYSTEM
I.
CODE: All Steris System I Quick
Connect Kit Processing Instructions for Pentax 30/40/30k series GI Gastroscopes;
Quick Connect Kits #C1402, C1403, and #C1622.
MANUFACTURER: Steris Corp., Mentor,
OH.
DISTRIBUTION: Nationwide and Canada,
Germany, Italy, and Mexico.
QUANTITY: 1,255 booklets (1 per
kit).
REASON: Inadequate instructions
may result in ineffective sterilization of water jet port.
PRODUCT: AngioJet® Rheolytic™
Thrombectomy System Pump Set.
CODE: All
lots.
MANUFACTURER: Possis Medical, Inc.,
Minneapolis, MN.
DISTRIBUTION: Nationwide and Australia,
Canada, England, Germany, Greece, Italy, Taiwan, and
Turkey.
QUANTITY: Estimated 2200 pumps in
distribution.
REASON: Holes in sterile
packaging.
PRODUCT: Flexilab Laboratory
Information System (not for use in blood
banks).
CODE: Flexilab version 5.23 with
RBR module.
MANUFACTURER: Sunquest Information
Systems, Inc., Tucson, AZ.
DISTRIBUTION: WI, WA, MI, VA, NM, OH,
AZ, and Denmark.
QUANTITY: 15
laboratories.
REASON: Software anomaly allows
misprint of patient information.
PRODUCT: Duracon Unicompartmental
Knee System:
Right Medial/Left Lateral
Small Tibial Component
Catalog No. 6634-9-108, 8 mm
Catalog No. 6634-9-110, 10 mm
Catalog No. 6634-9-112, 12 mm
Catalog No. 6634-9-114, 14 mm
Catalog No. 6634-9-116, 16 mm
Left Medial/Right Lateral
Small Tibial Component
Catalog No. 6634-9-008, 8 mm
Catalog No. 6634-9-010, 10 mm
Catalog No. 6634-9-012, 12 mm
Catalog No. 6634-9-014, 14 mm
Catalog No. 6634-9-016, 16 mm
Right Medial/Left Lateral
Medium Tibial Component
Catalog No. 6634-9-308, 8 mm
Catalog No. 6634-9-310, 10 mm
Catalog No. 6634-9-312, 12 mm
Catalog No. 6634-9-314, 14 mm
Catalog No. 6634-9-316, 16 mm
Left Medial/Right Lateral
Medium Tibial Component
Catalog No. 6634-9-208, 8 mm
Catalog No. 6634-9-210, 10 mm
Catalog No. 6634-9-212, 12 mm
Catalog No. 6634-9-214, 14 mm
Catalog No. 6634-9-216, 16 mm
Right Medial/Left Lateral
Medium/Large Tibial Component
Catalog No. 6634-9-508, 8 mm
Catalog No. 6634-9-510, 10 mm
Catalog No. 6634-9-512, 12 mm
Catalog No. 6634-9-514, 14 mm
Catalog No. 6634-9-516, 16 mm
Left Medial/Right Lateral
Medium/Large Tibial Component
Catalog No. 6634-9-408, 8 mm
Catalog No. 6634-9-410, 10 mm
Catalog No. 6634-9-412, 12 mm
Catalog No. 6634-9-414, 14 mm
Catalog No. 6634-9-416, 16 mm
Right Medial/Left Lateral
Large Tibial Component
Catalog No. 6634-9-708, 8
mm
Catalog No. 6634-9-710, 10 mm
Catalog No. 6634-9-712, 12 mm
Catalog No. 6634-9-714, 14 mm
Catalog No. 6634-9-716, 16 mm
Left Medial/Right Lateral
Large Tibial Component
Catalog No. 6634-9-608, 8 mm
Catalog No. 6634-9-610, 10 mm
Catalog No. 6634-9-612, 12 mm
Catalog No. 6634-9-614, 14 mm
Catalog No. 6634-9-616, 16 mm
Right Medial/Left Lateral
Extra Large Tibial Component
Catalog No. 6634-9-908, 8 mm
Catalog No. 6634-9-910, 10 mm