JUNE 2003

 

WEEK ENDING JUNE 7

PRODUCT a) Portex 1st Response Adult Manual Resuscitators REF 8506P, expandable tube reservoir, peep valve.

b) Portex 1st Response Adult Manual Resuscitators REF 8500P, Bag Reservoir, peep valve.
c) Portex 1st Response Adult Manual Resuscitators REF 8503P, 40" tube reservoir.
CODE a) Lot #'s 020624, 020705, 021003, 200205, 200214, 200216;
b) Lot #'s 020607, 020620, 020622, 020703, 020710, 020829, 200214, 200215, 200216;
c) Lot #'s 020624, 020702, 020917, 021003, 200205, 200214, 200216.
RECALLING FIRM/MANUFACTURER Sims Portex, Inc., Keene, NH,
REASON Peep valve set at the highest level and could result in patient injury.
VOLUME OF PRODUCT IN COMMERCE 10,416 units.
DISTRIBUTION Nationwide.

 

PRODUCT Aeroset Analyzer, item 9D05-01.
CODE All units on the market prior to 12/3/2001.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
VOLUME OF PRODUCT IN COMMERCE 238 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Aeroset Analyzer.
CODE All Aeroset devices distributed prior to 08/15/2002.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
VOLUME OF PRODUCT IN COMMERCE 578 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT a) GEM Premier 3000 Pak pH, pC02, p02, Hct Sensor and Reagent Cartridge Part No. 24330004 (300 Sample Size) For In-Vitro
Diagnostic Use.
b) GEM Premier 3000 Pak Sensor pH, pC02, p02, Hct and Reagent Cartridge Part No. 24345004 (450 Sample Size) For In-Vitro
Diagnostic Use.
CODE  a) Lot Number: 306355 Expires: 8/31/2003;
b) Lot Number: 306360 Expires: 8/31/2003.
RECALLING FIRM/MANUFACTURER Instrumentation Laboratory, Co., Lexington, MA,
REASON Incorrect bar code applied to cartridges could result in inaccurate p02 value.
VOLUME OF PRODUCT IN COMMERCE 18 cartridges.
DISTRIBUTION CA, FL, NY, PA, and TN.

PRODUCT a) "Hello Kitty", Plaque Removing Powered Toothbrush, Model HK70W.
b) "NASCAR", Electric Powered Toothbrush, Model NC70.
RECALLING FIRM/MANUFACTURER Gimelli No: 7625.006; Emerson #: HK70W; Gimelli No: 7625.005; Emerson #: NC70.
REASON Powered toothbrushes are exploding due to gas build-up.
VOLUME OF PRODUCT IN COMMERCE 24,564 brushes.
DISTRIBUTION Nationwide.

PRODUCT a) Nutriline with Peelable Sheath 2 Fr. Peripherally inserted Catheter (PIC). Included with this catheter is a 2 Fr. Insertion
sheath. Product is packaged in tyvek sealed plastic tray.
b) Neonatal Catheter & Insertion Tray is a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. Catheter and
a separately packaged catheter tray. 
CODE a) Lot #B01A48 Exp. 11/2007;
b) Lot #31203MA Exp. 7/1/2005.
RECALLING FIRM/MANUFACTURER Vygon Corporation, East Rutherford, NJ,
REASON Nutriline with Peelable Sheath 2 Fr. And Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. Insertion sheath.
VOLUME OF PRODUCT IN COMMERCE 71.
DISTRIBUTION MA, NY, GA, FL, OH, CO, and CA.

PRODUCT Gent-L-Kare Sterile Mid-Stream Urine Collector. Gent-L-Kare Sterile 3OZ. Ear/Ulcer Bulb Syringe Single Use.
CODE Catalog # 4150, Lot number 037667A2. Catalog # 4173, Lot number 038594A1.
RECALLING FIRM/MANUFACTURER Medegen Medical Products, LLC, Northglenn, CO,
REASON Finished products were not sterilized.
VOLUME OF PRODUCT IN COMMERCE 32,800 units.
DISTRIBUTION Nationwide, Canada, and Saudia Arabia.

PRODUCT Cryo Valve Allograft, Pulmonary Heart valve & Conduit.
CODE Model #PVOO, Serial #7916346.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA,
REASON Microorganisms were detected in associated allografts after initial release of donor.
VOLUME  OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Multi-Link Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13.
CODE Lot 3021951.
RECALLING FIRM/MANUFACTURER Guidant Corporation ACS, Temecula, CA,  

REASON Sterility compromised.
VOLUME OF PRODUCT IN COMMERCE 40.
DISTRIBUTION Nationwide.

PRODUCT Cryo Valve Allograft, Heart valve.
CODE Donor #61838, Serial #7691913, Model #SGPVOO; Donor #65235, Serial #7915089, Model #SGAVOO; Donor #64922, Serial #7883079, Model #SGAVOO; Donor #64779, Serial #7883080, Model #SGPVOO; Donor #64779, Serial #7888910, Model #SGPVOO; Donor #64779, Serial #7888909, Model #SGAVOO; and Donor #63941, Serial #7894710, Model #SGPVOO.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, 
REASON Microorganisms were detected in associated allografts.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION CA, and IL.

PRODUCT Misys Laboratory System.
CODE Versions 5.2, 5.23, 5.3, 5.3.1, and 5.3.2.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ,
REASON Incorrect results could be filed.
VOLUME OF PRODUCT IN COMMERCE 193.
DISTRIBUTION Nationwide, Ireland, Canada, Denmark, United Kingdom, Saudi Arabia, and United Arab.

PRODUCT Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
CODE Genesis 100, 150 & 200, Tecan PosID2 units with firmware version 2.5 or lower.
RECALLING FIRM/MANUFACTURER Tecan U.S. Inc., Durham, NC,
REASON Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.
VOLUME OF PRODUCT IN COMMERCE 327 instruments.
DISTRIBUTION Nationwide and Internationally.

PRODUCT a) Elecsys Troponin T; catalog number 2017644.
b) Elecsys Troponin T STAT; catalog number 2017423.
CODE All lots.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN,
REASON Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
VOLUME OF PRODUCT IN COMMERCE 26,961 kits.
DISTRIBUTION Nationwide.

PRODUCT Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.  CODE Product code number RF451. Lot number CD4085 Exp 3/25/04.
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE,
REASON Test results may be inaccurate by 0.2 to 0.5 ng/mL.
VOLUME OF PRODUCT IN COMMERCE 662 cartons.
DISTRIBUTION Nationwide.


PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software.
CODE a) Serial Numbers: 3094 through 3196;
b) Serial Numbers: 3008 through 3169.
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland), Inc., Highlands Heights, OH,
REASON Patient images may be incorrectly stored in the archive directory of a different patient.
VOLUME OF PRODUCT IN COMMERCE 187 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Protege Self-Expanding Nitinol Stent 6 mm x 40 mm, model number SER6-40-135.
CODE Lot Number 132612.
RECALLING FIRM/MANUFACTURER Ev3, Inc., St. Paul, MN,
REASON The label has an expiration date of August 2005, but the correct expiration date is February 2005.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION Nationwide, and Internationally.

 

PRODUCT a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound  System; Catalog Numbers: 23656 (New), 45441 (Refurb).
b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound
System; Catalog Numbers: 23656 (New), 45441 (Refurb).
CODE All Serial Numbers: XXXXXXXX (8-digit).
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain View, CA,
REASON The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
VOLUME OF PRODUCT IN COMMERCE 220 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT ACCESS Estradiol Reagent Test System.
CODE Lot number 215173.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA,
REASON Short volume, resulting possibility of falsely elevated results.
VOLUME OF PRODUCT IN COMMERCE 1,593 kits.
DISTRIBUTION Nationwide and Canada.

 

WEEK ENDING JUNE 14


PRODUCT

a) Pulsar Multiprogrammable Pacemaker, DDD Model 970.
b) Pulsar Multiprogrammable Pacemaker, DDD Model 972.
c) Pulsar Multiprogrammable Pacemaker, DDD Model 976.
d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270.
e) Pulsar Multiprogrammable Pacemaker, DDDDR Model 1272.
f) Pulsar Max Multiprogrammable Pacemaker.
g) Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1284.
h) Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1286.
i) Discovery Multiprogrammable Pacemaker, DDDR Model 1273.
j) Discovery Multiprogrammable Pacemaker, DDDR Model 1274.
k) Discovery II Multiprogrammable Pacemaker, DDD Model 981.
l) Discovery II Multiprogrammable Pacemaker, DDDR Model 1280.
m) Discovery II Multiprogrammable Pacemaker, DDDR Model 1283.
n) Meridian Multiprogrammable Pacemaker, DDDR Model 1275.
o) Meridian Multiprogrammable Pacemaker, DDDR Model 1286.
p) Insignia Plus Multiprogrammable Pacemaker, DDD Model 985.
q) Insignia Plus Multiprogrammable Pacemaker, DDD Model 986.
r) Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1294.
s) Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295.
t) Insignia Extra Multiprogrammable Pacemaker, DDDR  Model 1296.
u) Insignia Extra Multiprogrammable Pacemaker, DDDR Model 1297.
v) Insignia Extra Multiprogrammable Pacemaker, DDDR  Model 1298.

w) Contak TR Multiprogrammable Pacemaker, DDDR Model 1241.
CODE All Serial numbers.
RECALLING FIRM/MANUFACTURER Guidant Corp-Cpi Division, St Paul, MN.
REASON In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
VOLUME OF PRODUCT IN COMMERCE 298,000.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
CODE Lot #115496, Exp. 11/1/03.
RECALLING FIRM/MANUFACTURER PerkinElmer Life Sciences Inc., Norton, OH.
REASON The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
VOLUME OF PRODUCT IN COMMERCE 75 kits.
DISTRIBUTION WI, AR, and MI.


PRODUCT STA-Compact Hemostasis System with Cap piercing capability.
CODE All distributed units with cap piercing option.
RECALLING FIRM/MANUFACTURER Diagnostica Stago, Inc., Parsippany, NY.
REASON With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
VOLUME OF PRODUCT IN COMMERCE 137.
DISTRIBUTION Nationwide.

PRODUCT Misys Laboratory versions 5.2, 5.23 and 5.3 using Cache Database with linked CPUs.
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Customer reports that the processor failed to make patient report updates with two processors running in the LABB area.
VOLUME OF PRODUCT IN COMMERCE 38.
DISTRIBUTION Nationwide.

PRODUCT Trident Insert Impactor.
CODE Catalog Number: 2111-0000.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
VOLUME OF PRODUCT IN COMMERCE 1,758.
DISTRIBUTION Internationally.

PRODUCT
a) Hill-Rom brand Affinity three birthing bed.

b) Hill-Rom brand Century+ series bed.
CODE All units distributed between January 1, 1999 and July 1, 2002.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
VOLUME OF PRODUCT IN COMMERCE 12,848.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Dermagraft, Human Fibroblast-Derived Dermal Substitute,  2 in. by 3 in.
CODE Lot 116098.
RECALLING FIRM/MANUFACTURER Smith and Nephew Wound Management (La Jolla), San Diego, CA.
REASON Did not meet finished device specifications for DNA criteria.
VOLUME OF PRODUCT IN COMMERCE 22.
DISTRIBUTION Nationwide.

PRODUCT
a) Rascal Powered Scooters. 
b) Chauffeur Powered Scooters. 
CODE a) Rascal Model Numbers 205, 215, 235, 245, 255, 305, 400 There are 45,679 serial numbers.
b) Chauffeur Model Numbers are C205, C215, C235, C245, C255, and C305. There are 45,679 serial numbers involved.
RECALLING FIRM/MANUFACTURER Electric Mobility Corp., Sewell, NJ.
REASON The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
VOLUME OF PRODUCT IN COMMERCE 45,679.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT
a) Inject 10 Coronary Control Syringe (CCS), 10ml.
b) Custom Kit.
CODE a) REF/CAT No.: CCX010, Lot No's. A257336, A258248, A258893, A263340;

b) REF/CAT No.: K09-03442C. Lot No. A259058.
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT.
REASON Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
VOLUME OF PRODUCT IN COMMERCE 7,277 units.
DISTRIBUTION Nationwide, and France, Malaysia, Taiwan, and Dominican Republic.

PRODUCT 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11" introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.
CODE REF or Order #0684-00-0195-02; P/N #0684-00-0438; Lot #BRV; Exp. Date 03/03/05.
RECALLING FIRM/MANUFACTURER Datascope Corp., Fairfield, NJ.
REASON 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION Nationwide.

PRODUCT COBAS TaqMan analyzer, Series 96; catalog number 8080216.
CODE All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Inc., Belleville, NJ.
REASON A false positive result may be reported.
VOLUME OF PRODUCT IN COMMERCE 16.
DISTRIBUTION Nationwide.

PRODUCT 2.75 mm Slit Knife, Angled, Bevel Up. Labeled "Stylus 2.75 mm Slit Knife Angled, Bevel, Up One Unit STERILE R Disposable Surgical Specialties Corporation Reading, PA 19606".
CODE Model number: 52-2761 Lot/Serial # Exp. Date M262530 2/2008, M262540 3/2008, M262550 3/2008.
RECALLING FIRM/MANUFACTURER Surgical Specialties Puerto Rico, Inc., Rincon, PR.
REASON Incorrect handle was used in the manufacture of product 52-2761.
VOLUME OF PRODUCT IN COMMERCE 3,420 pieces.
DISTRIBUTION Nationwide and worldwide.

PRODUCT Misys Commercial Laboratory version 2.x thru 3.4.1.
CODE Versions 2.x through 3.4.1.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Urgent care STAT reports are not printing in a timely fashion.
VOLUME OF PRODUCT IN COMMERCE 109.
DISTRIBUTION Nationwide and Canada.


PRODUCT
a) LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset.
b) LifeShield Latex-Free Microdrip Soluset100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port.
CODE
a) Product number 19292-04-01, lots 961815H and 921675H;
b) Product number 19289-04-02, lot 960445H.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL.
REASON IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
VOLUME OF PRODUCT IN COMMERCE 12,840 units.
DISTRIBUTION Nationwide.


PRODUCT Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
CODE All slide lots with coatings "0292" and "0293". The coating lot numbers are seen as "xxxx-0292-xxxx" and "xxxx-0293-xxxx" in the lot number.
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY.
REASON Slides may exhibit random, elevated imprecision of results.
VOLUME OF PRODUCT IN COMMERCE 29,273 (domestic); 4,967 (international).
DISTRIBUTION Nationwide, and Internationally.

 

WEEK ENDING JUNE 28


PRODUCT Stryker Secure II hospital bed; model 3002.
CODE Serial numbers 030415710, 030415711, 030415712, 030415713, 030415714 and 030415729.
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI

REASON A wire may break at the crimp and present a potential electric shock hazard.
VOLUME OF PRODUCT IN COMMERCE 6
DISTRIBUTION PA, and KS.


PRODUCT a) Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i. Non Sterile Contents must be sterilized prior to use. RX only.
b) Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i. Non Sterile Contents must be sterilized prior to use.

RX only.
CODE a) Lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769;
b) Lot numbers 127726 and 191427.
RECALLING FIRM/MANUFACTURER Implant Innovations, Inc., Palm Beach Gardens, FL

REASON Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
VOLUME OF PRODUCT IN COMMERCE 200.
DISTRIBUTION Nationwide, and Internationally.

 

PRODUCT StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6" LL. Model Number 2N9205K.
CODE Lot D207201.
RECALLING FIRM/MANUFACTURER Venetec Intl, Inc., San Diego, CA.,

REASON Set tubing disconnected from the male luer lock during use on patients. Misassembled.
VOLUME OF PRODUCT IN COMMERCE 500 units.
DISTRIBUTION CT, IN, PA, and TN.


PRODUCT Misys Laboratory System.

CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Two clients reported Quality Assurance dates could not be entered after 5/19/03.
VOLUME OF PRODUCT IN COMMERCE 466.
DISTRIBUTION Nationwide and Internationally.


PRODUCT a) System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Box Includes Delivery
system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Unit is intended to provide oxygen for emergency use.
b) Rejuv O2 Home Oxygen Spa - 98% + Pure, Non-pressurized Oxygen for Breathing. Reusable system. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA.  
CODE All units are under recall.
RECALLING FIRM/MANUFACTURER System O2, Inc., Roswell, GA.
REASON System 02 oxygen flow rate found to be inadequate and Rejuv 02 Home Oxygen Bar contains 'Adulterated Labeling'.
VOLUME OF PRODUCT IN COMMERCE 2000 units.
DISTRIBUTION GA.


PRODUCT Line Powered RePaks, Model Number 1785S.
CODE Between 04/09/03 and 05/07/03, (Model 1785S) were shipped.
RECALLING FIRM/MANUFACTURER Rehabilicare, New Brighton, MN.
REASON If there is a short, excessive heat could be generated in the transformer due to the use of the wrong fuse.
VOLUME OF PRODUCT IN COMMERCE 618 Line Powered RePaks.
DISTRIBUTION Nationwide.


PRODUCT Synapse.
CODE Version 2.2.1 and 2.3.1.
RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT.

REASON Synapse Version 2.2.1 and 2.3.1.
VOLUME OF PRODUCT IN COMMERCE 54 units.
DISTRIBUTION Nationwide, Canada, Germany, Isrel, and Japan.


PRODUCT Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.
CODE Catalog #352004 - Lot #s 0060390643, 0060390644, 0060395269, 60395272, 60429525, 0060411651, 0060426960, 0060429525, and 0060430054;
Catalog #352049 - Lot #s 0060381759, 0060384115, 0060386555, 0060388678, 0060391072, 0060392950, 0060397344, 0060399612, 0060405055, 0060406467, 0060408425, 0060410255, 0060411638, 0060412823, 0060419500, 0060421552, 0060426399, 0060429531, 0060430749, 0060435319, 0060437596, and 0060437913;
Catalog #352051 - Lot #s 0060419038 and 0060419039; Catalog #352222 - Lot #s 0060381626, 0060386862, 0060390599, 0060393331, 0060397325, 0060411966, 0060417244, 0060420643, and 0060429830;
Catalog #352223 - Lot #s 0060395209, 0060420353, and 0060432419;
Catalog #352224 - Lot # 0060374720;
Catalog #352225 - Lot #s 0060406237, 0060411540, and 0060417245; Catalog #352237 - Lot #s0060386868, 0060384090, 0060397352,
006042859, 0060435289 and 0060393337;
Catalog #352238 - Lot #s 0060379443, 0060413601, 0060419352 and 0060397391;
Catalog #352340 - Lot # 0060399651;
Catalog #352341 - Lot #0060419800;
Catalog #352342 - Lot #s 0060385368 and 0060386187;
Catalog #352355 - Lot #s 0060381731, 0060386533, 060405539, and 0060421540;
Catalog #352356 - Lot #s 0060384095, 0060405753, 060412569, 0060419498, and 0060428603;
Catalog #352362 - Lot # 0060390627;
Catalog #352379 - Lot #s 0060386755 and 0060390530;
Catalog #352393 - Lot #s 0060379061, 0060386808, 060390531, 0060395158, 0060397119, and 0060417162;
Catalog #352396 - Lot #s 0060379062, 0060385889, 060390534, 0060397122, and 0060408823;
Catalog #352406 - Lot #s 0060388274, 0060395165, 060397235, 0060408828, 0060411870, and 0060420593;
Catalog #352409 - Lot # 0060388275;
Catalog #352413 - Lot #s 0060397890, 0060409013, 060411626, and 0060411975;

Catalog #352420 - Lot #s 0060406524, 0060412700, 060421691, 0060432013, 0060432988, and 0060433472;
Catalog #352421 - Lot #s 0060404049, and 0060411708; Catalog #352422 - Lot #s 0060404062, 006040908, and 0060417538;
Catalog #352423 - Lot # 0060404052;
Catalog #352444 - Lot # 0060417840;
Catalog #352446 - Lot # 0060417838;
Catalog #352455 - Lot # 0060417841;
Catalog #375038 - Lot #s 0060406603 and 0060408468;
Catalog #375084 - Lot #s 0060397187 and 0060422174;
Catalog #375088 - Lot #s 0060381216, 0060386872, and 0060417250;
Catalog #375090 - Lot #s 0060386873, 0060411552, and 0060417251;
Catalog #375100 - Lot #s 0060381725, 0060384081, 0060384082, 0060385182, 0060388670, 0060388671, 0060391024, 0060395171, 0060395185, 0060398414, 0060403467, 0060403471, 0060408406, 0060408407, 0060408408, 0060410249, 0060411025, 0060412517, 0060412992, 0060413598, 0060418255, 0060418257, 0060418455, and 0060421541;
Catalog #375101 - Lot #s 0060386532, 0060395172, 0060399599, 0060406462, 0060410025, 0060418444, 0060426298, 0060427317, and 0060438111;
Catalog #375105 - Lot #s 0060391170, 0060397412, 0060399667, 0060403501, 0060405234, 0060410306, 0060412697, 0060424455, 0060427890, 0060430736, and 0060432994;
Catalog #375135 - Lot # 0060393350;
Catalog #375151 - Lot #s 0060399411, 0060408845, and 0060424446;
Catalog #375155 - Lot #s 0060408847 and 0060419024;
Catalog #472033 - Lot #s 0060373796, 0060373797, 0060373800, 0060378892, 0060378893, and 0060378894;

Catalog #473436 - Lot #s 0060385366, 0060386542, 0060395227, 0060423199, 0060424318, 0060425256, 0060425671, 0060428044, and 0060432415;
Catalog #473992 - Lot # 0060432401;
Catalog #474516 - Lot # 0060401098;
Catalog #474577 - Lot #s 0060381183, 0060382531, 0060388314, and 0060411522;
Catalog #474912 - Lot #s 0060398364 and 0060417227;
Catalog #CC1260-SP02 - Lot #s 0060428236, 0060432935, 0060438115, and 0060432936;
Catalog #S5403001N - Lot #s 0060378529, 0060380587, 0060387639, 0060392813, and0060407453;
Catalog #S9903301N - Lot # 0060418246;
Catalog #US1380 - Lot #s 0060391069 and 0060403474;
Catalog #US3115 - Lot #s0060387950, 0060388508, 0060406192, 0060410297, 0060419358, 0060419972, 0060426441, and 0060428624;
Catalog #US3116 - Lot # 0060410763;
Catalog #US3120 - Lot #s 0060386610, 0060397408, 0060406515, 0060410310, 0060413656, 0060424458, 0060427887, and0060435342;
Catalog #US3130 - Lot #s 0060381801, 0060384195, 0060386619, 0060386621, 0060386792, 0060387920, 0060387921, 0060388758, 0060390219, 0060391167, 0060391168, 0060393010, 0060395363, 0060395364, 0060395373, 0060397407, 0060398938, 0060403494, 0060403495, 60405210, 60408590, 0060406071, 0060408480, 0060408485, 0060408590, 0060412691, 0060412692, 0060413650, 0060413651, 0060417595, 0060418182, 0060419378, 0060419381, 0060419384, 0060421685, 0060421687, 0060423935, 0060424451, 0060424452, 0060424453, 0060424459, 0060424460,
0060424699, 0060425148, 0060426360, 0060426361, 0060427884, 0060427885, 006040058, 0060430943, 0060430944, 0060430945, 0060435339, 0060435816, 0060437605, 0060437607, and 0060437609;
Catalog #US3131 - Lot #s 0060385347, 0060385365, and 0060386180;
Catalog #US3169 - Lot #s 0060397410 and 0060413655;
Catalog #US3485 - Lot #s 0060384044, 0060397229, 0060408385, 0060410245, 0060413662, 0060420137, 0060421697, 0060432014, and 0060435399;
Catalog #US3488 - Lot #s 0060386525 and 0060412568; Catalog #US5300 - Lot #s S-0776, S-0777, S-0778, S-0903, 30049, 30096, 30149, and 30150;
Catalog #US6413 - Lot #s 0060381721, 0060397240, 0060403462, 0060411045, 0060411635, 0060412564, 0060418436, and 0060432400;
Catalog #US6415 - Lot #s 0060386526 and 0060412567;
Catalog #V5534-SP02 - Lot #s 0060405704 and 0060417228.
RECALLING FIRM/MANUFACTURER Braun, B Medical, Inc., Allentown, PA, by letters dated April 14, 2003. Firm initiated recall is ongoing.
REASON Possible leakage.
VOLUME OF PRODUCT IN COMMERCE 2,577,300 units.
DISTRIBUTION Nationwide, Germany, Canada, and Spain.


PRODUCT T-U-R-Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02.
CODE List number 15252-04-02, lot 940285H.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL

REASON The irrigation set was mislabeled with the wrong delivery rate of 8 drops/ml when it actually has a delivery rate of ll drops/mL.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION LA.


PRODUCT Sanarus brand Centrica( Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack).
CODE Lot # 28090403.
RECALLING FIRM/MANUFACTURER Sanarus Medical Inc., Pleasanton, CA.
REASON Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
VOLUME OF PRODUCT IN COMMERCE 83 units.
DISTRIBUTION MD, TN, TX, OH, and IL.

 

PRODUCT Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020.
CODE List number 19020-04-12, lot 941845H.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories HPD/ADD, Abbott Park, IL.
Manufacturer: Costa Rica, Abbott Laboratories, North Chicago, IL. Firm initiated recall is ongoing.
REASON The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL.
VOLUME OF PRODUCT IN COMMERCE 4,656 units.
DISTRIBUTION FL.


PRODUCT a) CryoValve Pulmonary Valve & Conduit.
b) CryoValve Pulmonary Valve & Conduit. Recall # Z0939-03.
CODE a) and b) Donor #64108, Serial #7984345, Model #PV00 and Donor #55416, Serial # 7253418, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Microorganisms detected in associated allografts.
VOLUME OF PRODUCT IN COMMERCE 2 individual heart valve allografts.
DISTRIBUTION CT.


PRODUCT LIFEPAK CR Plus defibrillator.
CODE All serial numbers below 31058753.
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA.
REASON Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE 7,095 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 8, 10 and 11 French sizes only).
CODE Catalog Numbers 401811M, 401923M, 401845M, 401935M, 401955M, 401911M, 401823 Also there are 636 specific lot numbers as follows: Catalog number Lot Number 401011M 40102114 401011M 40202950 401011M 40202950 401011M 40302315 401011M 40502170 401011M 41002991 401011M 41101111 401011M 41201721 401011M 41201898 401011M 50102160 401011M 50102160 401011M 50203190 401011M 50203190 401011M 50402054 401011M 50402054 401011M 50402323 401011M 50502275 401011M 51002576 401011M 51002576 401011M A0202879 401011M A0402425 401011M A0402425 401011M A0402809 401011M A0402809 401011M A0702953 401011M A0801019 401011M A0801298 401011M A0802511 401011M A1001609 401011M A1201755 401011M X0102305 401011M X0102305 401011M X0202591 401011M X0302562 401011M X0602226 401011M X0702049 401011M X0702828 401011M X0802394 401011M X0902132 401011M X0902535 401011M X1001444 401011M X1101158 401011M X1101717 401011M X1101717 401011M X1102221 401023M 40103575 401023M 40202378 401023M 40302816 401023M 40302816 401023M 40502368 401023M 40602515 401023M 41001756 401023M 41201511 401023M 50102176 401023M 50103742 401023M 50203192 401023M 50402141 401023M 50402141 401023M A0202574 401023M A0402445 401023M A0402445 401023M A0502351 401023M A0502351 401023M A0702965 401023M A0801240 401023M A0802518 401023M A0901911 401023M A1002290 401023M A1101856 401023M A1102652 401023M A1201677 401023M X0103383 401023M X0202812 401023M X0402634 401023M X0502655 401023M X0602239 401023M X0701056 401023M X0702030 401023M X0702835 401023M X0802402 401023M X0902137 401023M X1001459 401023M X1002715 401023M X1101732 401023M X1102232 401111M 40502481 401111M 40602534 401111M 40702040 401111M 40702040 401111M 41201722 401111M 50402324 401111M 50502276 401111M A0202594 401111M A0302241 401111M A0302241 401111M A0402426 401111M A0402426 401111M A0602559 401111M A0602559 401111M A0802631 401111M A1002395 401111M A1002395 401111M A1002418 401111M A1102643 401111M X0102205 401111M X0102205 401111M X0102205 401111M X0402517 401111M X0702829 401111M X0802395 401111M X0802537 401111M X1002704 401111M X1102222 401123M 40402551 401123M 40702044 401123M 40802500 401123M 41001594 401123M 41201512 401123M 50102177 401123M 50102177 401123M A0402446 401123M A0402838 401123M A0602028 401123M A0602993 401123M A0602993 401123M A1002394 401123M A1202284 401123M X0202203 401123M X0402153 401123M X0702681 401123M X0702685 401123M X0702685 401123M X0802403 401123M X0802538 401123M X1002710 401123M X1101733 401123M X1102233 401805M 40502356 401805M 40502791 401805M 40702534 401805M 41102050 401805M 41102059 401805M 50702455 401805M 51002382 401805M 51102323 401805M A0802599 401805M X0502531 401805M X0802151 401811M 40102003 401811M 40102003 401811M 40102637 401811M 40102866 401811M 40202479 401811M 40202479 401811M 40302143 401811M 40302143 401811M 40302827 401811M 40402550 401811M 40402550 401811M 40602096 401811M 40602369 401811M 40702580 401811M 40802491 401811M 41001442 401811M 41001742 401811M 41002003 401811M 41002796 401811M 41002796 401811M 41002853 401811M 41101500 401811M 41102051 401811M 41102060 401811M 41201547 401811M 41201547 401811M 41201547 401811M 41201901 401811M 41201901 401811M 50102161 401811M 50402539 401811M 50502281 401811M 50702456 401811M 50702492 401811M 51002383 401811M 51002390 401811M 51102324 401811M 51102357 401811M A0203173 401811M A0203181 401811M A0302247 401811M A0302247 401811M A0402306 401811M A0402306 401811M A0402691 401811M A0702331 401811M A0702882 401811M A0802601 401811M A0902986 401811M A0902993 401811M A1002995 401811M A1101812 401811M A1102587 401811M A1102592 401811M A1201316 401811M A1201519 401811M X0102306 401811M X0102306 401811M X0202595 401811M X0402131 401811M X0402900 401811M X0702325 401811M X0802152 401811M X1001304 401811M X1002705 401811M X1101162 401811M X1102150 401823M 40102668 401823M 40202125 401823M 40202125 401823M 40202903 401823M 40302818 401823M 40602519 401823M 40702590 401823M 40802496 401823M 40802501 401823M 40902776 401823M 41002006 401823M 41002011 401823M 41002855 401823M 50702465 401823M 50702470 401823M 50802091 401823M 51002392 401823M 51002393 401823M 51102363 401823M 51102367 401823M A0202456 401823M A0202456 401823M A0302937 401823M A0402096 401823M A0402638 401823M A0402698 401823M A0402698 401823M A0602032 401823M A0602995 401823M A0702891 401823M A0802630 401823M A0902146 401823M A1002291 401823M A1102596 401823M A1102598 401823M X0103288 401823M X0202603 401823M X0202603 401823M X0202814 401823M X0202814 401823M X0402050 401823M X0402050 401823M X0402991 401823M X0502520 401823M X0602242 401823M X0702033 401823M X0802190 401823M X0902537 401823M X1002711 401823M X1102160 401835M 40602372 401835M 40702588 401835M 51102361 401835M A0502826 401835M A0602582 401835M A0902893 401835M A1102593 401835M X0502516 401835M X0802187 401845M 40102666 401845M 40103555 401845M 40302815 401845M 41001775 401845M 41002004 401845M 41102062 401845M 41201510 401845M A0202572 401845M A0302248 401845M A0402697 401845M A0502827 401845M A0502827 401845M A0502827 401845M A0602583 401845M A0702888 401845M X0402161 401845M X0502517 401845M X0702027 401845M X0802953 401855M 51102362 401855M A0302931 401855M A0702341 401855M A0902894 401855M A1102594 401855M X0402162 401855M X0402162 401855M X0402643 401855M X0502518 401855M X0702910 401855M X0802188 401890M 40303594 401890M 40402408 401890M 40802495 401890M A0602584 401890M A0702890 401890M A0902145 401890M A0902895 401890M A1102595 401890M A1102595 401890M X0103287 401890M X0302897 401890M X0402986 401890M X0502519 401911M 40102867 401911M 40402116 401911M 40602535 401911M 40602535 401911M 40702041 401911M 40902061 401911M 41002797 401911M 41002992 401911M 51002560 401911M 51002560 401911M A0502186 401911M A0502868 401911M A0802603 401911M A0802844 401911M A0802846 401911M A0902135 401911M A0902987 401911M A1002281 401911M A1002411 401911M A1102644 401911M A1202285 401911M A1202289 401911M X0202181 401911M X0402617 401911M X0402617 401911M X0402901 401911M X0502340 401911M X0502773 401911M X0602232 401911M X0602759 401911M X0702673 401911M X0702830 401911M X0802396 401911M X0902530 401911M X1101719 401911M X1102151 401923M 40302826 401923M 40502512 401923M 40602520 401923M 40902071 401923M 40902071 401923M 41002308 401923M 41002856 401923M 41002998 401923M 41002999 401923M 41101524 401923M 41201515 401923M 51002563 401923M 51002563 401923M A0202577 401923M A0502530 401923M A0602033 401923M A0702966 401923M A0902996 401923M A1102653 401923M A1102784 401923M A1201681 401923M A1202286 401923M X0102326 401923M X0402636 401923M X0402992 401923M X0702836 401923M X1102161 401935M 40502195 401935M 41001777 401935M 51002562 401935M 51002562 401935M A0402444 401935M A0702964 401935M A1002392 401935M A1101831 401935M A1202287 401935M X0202202 401935M X0202202 401935M X0502654 401935M X0702028 401935M X0802954 401935M X1101753 401945M 40502196 401945M 41201746 401945M 41201746 401945M 41201746 401945M A0602585 401945M A0802847 401945M A1102650 401945M A1202288 401945M X1101580 401955M 40902070 401955M A1102651 401955M X0402633 401955M X0602765 401955M X0802955 MODS11269 K0702051 MODS11269 K0702339 MODS11269 K0902002 MODS12042 K0702262 MODS12042 K0702514 MODS12042 K0902003 MODS12295 K0802187 MODS12295 K0802477 MODS17833 K0802476 MODS17833 K0802476 MODS17833 K0902093 MODS17833 K0902223 SRA0042 0107020177 SRA0042 0107020913 SRA0042 0108021047 SRA0042 0109020185 SRA0042 0109020750 SRA0104 A1202035 SRA0148 A0103819 SRA0148 A0103819 SRA0148 A1102193 SRA0148 X0203846 SRA0149 A1202352 SRAM09555 L0602445 SRAM09555 L0702695 SRAM09555 L0902006 SRAM16514 L0802484 SRAM16514 L0902398
RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL.
REASON Reports of broken or separated tips of the catheter sheath introducers.
VOLUME OF PRODUCT IN COMMERCE 49,022.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Temno Chiba Fine Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CH11815, Allegiance, Made in Dominican Republic.
CODE Catalog number CH11815, lot D03AB0594.
RECALLING FIRM/MANUFACTURER Cardinal Health, McGaw Park, IL.
REASON The product was shipped prior to being sterilized.
VOLUME OF PRODUCT IN COMMERCE 50 needles
DISTRIBUTION FL, GA, MN, OK, OH, MO, and Malaysia.


PRODUCT ThinPrep Microscope Slides for Non-Gynecologic Use Size 1" x 3" Reorder Number: 70214-001.
CODE Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293.
RECALLING FIRM/MANUFACTURER Cytyc Corp., Boxborough, MA.
REASON Microscope Slides contaminated with fungal material.
VOLUME OF PRODUCT IN COMMERCE 5,261 units.
DISTRIBUTION Nationwide.


PRODUCT IVIEW DAB Detection Kit. Catalog Number 760-091.
CODE Lot 400566.
RECALLING FIRM/MANUFACTURER Ventana Medical Systems, Inc., Tucson, AZ.
REASON Kit does not stain tissues properly.
VOLUME OF PRODUCT IN COMMERCE 409.
DISTRIBUTION Nationwide.