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
Catalog No. 6634-9-912, 12 mm
Catalog No. 6634-9-914, 14 mm
Catalog No. 6634-9-916, 16 mm
Left Medial/Right Lateral
Extra Large Tibial Component
Catalog No. 6634-9-808, 8 mm
Catalog No. 6634-9-810, 10 mm
Catalog No. 6634-9-812, 12 mm
Catalog No. 6634-9-814, 14 mm
Catalog No. 6634-9-816, 16 mm
CODE:All.
MANUFACTURER: Howmedica Osteonics
Corporation, Rutherford, NJ
DISTRIBUTION:
Nationwide.
QUANTITY: 247.
REASON: Polyethylene components
may be oxidizing.
PRODUCT: Surgical Procedure
Packs
CODE: Sterile Lot No.
2101578610.
MANUFACTURER: Sterile Recoveries, Inc.,
Clearwater, FL.
DISTRIBUTION:
Florida.
QUANTITY: 45.
REASON: The sterilization process
did not meet one temperature parameter.
PRODUCT: Fischer Needle Guide: a)
Catalog No. GF1200 (12 Gauge Needle Guide; b) Catalog No. GF1416 (14/16 Gauge
Needle Guide)
CODE: a) Lot No. 22FK3363; b)
Lot No. 22FK3362.
MANUFACTURER: C. R. Bardm Inc.,
Covington, GA.
DISTRIBUTION: CA, GA, MD, MI, NV, OH,
TN.
QUANTITY: 875
units.
REASON: Contains 12 gauge needle
guide but labeled as containing 14/16 gauge needles.
PRODUCT: Medtronic PT Cartridge,
Prothrombin Time Cartridge
CODE: Model 402-05, Lots
0005000402, 0005000446, 0006000188, 0006000245, 0006000381,
0007000206.
MANUFACTURER: Medtronic, Inc., Parker,
CO.
DISTRIBUTION: Nationwide, Cyprus,
Germany and Hungary.
QUANTITY: 342 boxes of
20.
REASON: Inactive thromboplastin
causes invalid clotting times.
PRODUCT: SEDRite Plus Hematology
Erythrocyte Sedimentation Rate Control
CODE: Lot
SR011-1.
MANUFACTURER: R & D Systems, Inc.,
Minneapolis, MN.
DISTRIBUTION:
Nationwide.
QUANTITY: 168
Kits.
REASON: Microbiological
contamination in the control caused the red blood cells to
lyse.
PRODUCT: Lifecore SuperCAT Self-Tap
Implant, NP Mnt 3.3x10 mm (SD), Titanium, Catalog number
TC3310
CODE: Lot
75001287.
MANUFACTURER: Lifecore Biomedical, Inc.,
Chaska, MN.
DISTRIBUTION: Nevada, New York and Chile
and Italy.
QUANTITY: 12
implants.
REASON: Dental implant mislabeled
as to length.
PRODUCT: Integrated Endosurgery
EndoALPHA Software Version 3.01.
CODE: Catalog #UCES (Control
Unit for Endosurgery), software version 3.01.
MANUFACTURER: Olympus America, Inc.,
Melville, NY.
DISTRIBUTION: CA, VA, AL, and
NV.
QUANTITY: 31.
REASON: The device software
version 3.01 prevented the control unit from retaining the user-programmer
coagulation setting.
WEEK
ENDING MARCH 23
PRODUCT: Puritan-Bennett® 840
Series™ Ventilator System.
CODE: All Serial Numbers with
Revision E Level Software.
MANUFACTURER: Puritan Bennett Corp.,
Carlsbad, CA.
DISTRIBUTION: Nationwide and
International.
QUANTITY: 656
units.
REASON: A malfunction may result in
overpressure and barotrauma that could lead to serious injury or death in
patients whose body weight is less than 20 kg.
PRODUCT: a) Model No. XGS dual gas
spring portable mobile stand; b) Model No. XGS Mark II dual gas spring portable
mobile stand.
CODE: Model numbers XGS and XGS
Mark II.
MANUFACTURER: Royal Enterprises, Helmet,
CA.
RECALLED
BY:
MinXray, Inc., Northbrook, IL
DISTRIBUTION:
Nationwide.
QUANTITY: 292
units.
REASON: Failure of the device’s
mounting stud may allow the trunnion of the xray unit to unintentionally
separate from the tube arm and allow the xray unit to
fall.
PRODUCT: InterOp Acetabular Shell:
a) Hemispherical, Catalog No. 4360-00-039/065; b) Revision, Catalog No.
4361-00043/081;
c)
Rim Flare, Catalog No. 4361-00-039/071; d) Protrusion, Catalog No.
4363-00-053/081
CODE: a) Lot Nos. 1307848 and
Higher; b) All Lot Numbers; c) Lot Nos. 1398234 and Higher; d) Lot Nos. 1397531
and Higher.
MANUFACTURER: Sulzer Orthopedics, Inc.,
Austin, TX
DISTRIBUTION: Nationwide and
International.
QUANTITY: 10,114
devices.
REASON: The device contains a
manufacturing residue, machining oil.
PRODUCT: Safety Seals, Catalog No.
SS
CODE: Lot Nos. 5031 through
5341.
MANUFACTURER: Midas Rex, L.P., Fort
Worth, TX.
DISTRIBUTION: Nationwide and
International.
QUANTITY: 100,548
units.
REASON: The safety seals may swell
during autoclaving which can cause the migration of the seals to an incorrect
position within the motor-attachment assembly resulting in an increased chance
of oil leaks and seal disintegration during surgery.
PRODUCT: Immolate brand of Valproic
Acid Test Kit
CODE: Lot No. 105, Model No.
LKVAI.
MANUFACTURER: Diagnostic Products Corp,
Los Angeles, CA.
DISTRIBUTION: Arizona and
International.
QUANTITY: 14
kits.
REASON: The barcode used to label
the adjustor kit component had an error that caused the system to reject
it. The printing error prevents
the
barcode from being read and the instruments will not process the assay and
patient results will not be obtained.
PRODUCT: a) Vitros 250 and Vitros
250 AT Chemistry Systems Software version below 7.0.; b) Vitros 950 and Vitros
950AT Chemistry Systems with software version below 3.07.
CODE: a) Model No. 3332, Catalog
No. 8132086 (Vitros 250); Model No. 3391, Catalog No. 1558143 (Vitros 250AT); b)
Model No. 3360, Catalog No. 8748790 (Vitros 950); Model No. 3361, Catalog No.
1735356 (Vitros 950AT).
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and
International.
QUANTITY: a) 279 devices; b) 18
devices.
REASON: The Bilirubin
(Unconjugated Bilirubin) results may be reported as 0.0 mg/dL or Bc (Conjugated
Bilirubin) result may not be flagged
with a potential interferent
code when a spectral interferent is present in a patient sample.
PRODUCT: Vitros Clinical Chemistry
- Performance Verifier I. Kodatrol I and II Control and Diluent Set, Model and
Catalog Numbers Performance Verifier I, Catalog No. 806 7324.
CODE: Lot No. X1815, Exp. 30 Jun
02.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and
International.
QUANTITY: 8,928 kits.
REASON: Sodium QC results may run
above the published Range-of-Means (ROM) on some analyzers with this lot of
Performance Verifier control fluid.
PRODUCT: VITROS Immunodiagnostic
Product: a) Ferritin Reagent Pack, Catalog No. 835 6636; b) Total B-hCG Reagent
Pack
CODE: a) Lot No. 134; b) Lot No.
144.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and
International.
QUANTITY: a) 983 kits; b) 1,033
kits.
REASON: Incorrect placement of
reagent bottles in the reagent pack.
The incorrect configuration will cause very low light signal, which will
result in either failure to calibrate, an error code, or signal results of 0
ng/mL.
PRODUCT: Vitros Immunodiagnostic
Products CA 15-3™ Reagent Packs,
Catalog No. 6800039
CODE: Lot No.
80.
MANUFACTURER: Ortho-Clinical
Diagnostics, Inc., Rochester, NY.
DISTRIBUTION: Nationwide and
International.
QUANTITY: a) 22 kits; b) 173
kits.
REASON: Reagent bottles are
incorrectly positioned in these products and using them would produce CA 15-3
results of less than 1U/ml.
PRODUCT: Rifton Chairs: a) Small,
low back;b) Medium, low back;c) Medium, high back;d) Medium, low back; e) Large,
high back
CODE: All Serial Numbers: a)
Model No. R501; b) Model No. R502; c) Model No. R503; d) Model No. R504; e)
Model No. R505.
MANUFACTURER: Community Products
LLC/Community Playthings, Rifton, NY
DISTRIBUTION: Nationwide and
International.
QUANTITY: 3,567
chairs.
REASON: The plastic housing, into
which the brackets that hold the seat is inserted have
broken.