ENFORCEMENT REPORT FOR October 8, 2003

OCTOBER 2003

WEEK ENDING OCTOBER 11

PRODUCT VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number 30101.
CODE Lot Numbers 040212-0, 040218-0 Expiration date 2/2004.
RECALLING FIRM/MANUFACTURER BioMerieux, Durham, NC.
REASON Product's decrease in sensitivity may result in false negative results.
VOLUME OF PRODUCT IN COMMERCE 2,204.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Disetronic H-TRON V100 Insulin Pump, catalog # 8010030C (clear case) and 8010030 (solid-color case).
b) Disetronic H-TRONplus Insulin Pump, catalog # 8050023 (clear case), 8050064 (blue case), 8050021 (solid-color case) and

8050071 (yellow case).
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN.

Manufacturer: Disetronic Medical Systems AG.
REASON Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
VOLUME OF PRODUCT IN COMMERCE 2,082.
DISTRIBUTION Nationwide.

PRODUCT Disetronic D-TRONplus Insulin Pump.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN.
REASON Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
VOLUME OF PRODUCT IN COMMERCE 8,000.
DISTRIBUTION Nationwide.

PRODUCT
a) Bard PEG Safety System "Guidewire" Reorder Number 000930.
b) Bard Ponsky PEG Safety System "Pull" Reorder Number 001925.
c) Bard Ponsky PEG Safety System "Pull" Reorder Number 001927.
d) Bard PEG Safety System "Guidewire" Reorder Number 001928.
CODE
a) Lot Number 43FNA080, 43FNA081, 43FNA179;
b) Lot Number 43FNA086;
c) Lot Number 43FNA088;
d) Lot Number 43FNA090.
RECALLING FIRM/MANUFACTURER Bard Endoscopic Technologies, Billerica, MA.
REASON Mislabeled kit: Prefilled Lidocaine syringe is labeled "sterile fluid path only", outer label states kit content is sterile.
VOLUME OF PRODUCT IN COMMERCE 538 units.
DISTRIBUTION Nationwide.

PRODUCT CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305.
CODE Lot Number JCQ3141 Expiration Date: May 2004.
RECALLING FIRM/MANUFACTURER Blue Torch Medical Technologies, Ashland, MA.
REASON Products sterility is compromised due to a failed sterility audit.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION NY and TX.

PRODUCT Calculator/Data Processing Module for Clinical Use.
CODE Verison 5.3 through 5.3.2.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software Defect.
VOLUME OF PRODUCT IN COMMERCE 466.
DISTRIBUTION Nationwide.

PRODUCT Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs).
CODE Serial Numbers: 50139962-2, 50128299-4, 50139968-5, 50139963-5, 50116580-5, 50128299-5, 50139964-2, 50139962-1, 50139971-2, 50139968-1, 50139964-3, 50128295-2, 50139964-1, 50139968-2, 50139964-4, 50128299-3, 50116576-2, 50128299-2, 50139968-3, 50139963-2, , 50139968-4, 50139963-4, 114766-1,114766-2.
RECALLING FIRM/MANUFACTURER The Anspach Effort, Inc., Palm Beach Gardens, FL.
REASON Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
VOLUME OF PRODUCT IN COMMERCE 24.
DISTRIBUTION FL, GA, NC, TX, CA, MA and MS.

PRODUCT Disetronic Dahedi insulin infusion pump; catalog # 8500019.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Lack of assurance of reliability.
VOLUME OF PRODUCT IN COMMERCE 296.
DISTRIBUTION Nationwide.

PRODUCT
a) ETHICON brand surgical device. The product described on label is a Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75.
b) ETHICON brand surgical device. The product described on label is a: 5mm Curved Shears, Scissors Grip Handle 14cm Item Code CS14C
c) ETHICON brand surgical device. The product described on label is a: Reloads for Devices EZ45, ET45, NK45 Thick Tissue, item ZR45G.

d) ETHICON brand surgical device. The product described on label is a: Linear Cutter, Thick tissue 75 mm, item code TCT75.
e) ETHICON brand surgical device. The product described on label is a: Cutter, Linear 55mm and 75mm, item numbers TCT75 and TLC55.
f) ETHICON brand surgical device The product described on label is a: Laparosonic coagulating curved Pistal grip 5 mm, curved,

Item Number LCSC5.
g) ETHICON brand surgical device. The product described on label is a: Blade, 5 mm Curved Harmonic, item HC325.
h) ETHICON brand surgical device. The product described on label is a: Stapler EMS Endo Hernia , item # 8034.
i) ETHICON brand surgical device. The product described on label is a: TX Stapler, Reloadable, Linear 30 mm and 60 mm, item numbers TX30 and TX60.
j) ETHICON brand surgical device. The product described on label is a: Stapler, Posered LDS Single Use, item # 092001.
k) ETHICON brand surgical device The product described on label is a: Stapler, Articulating, Linear, item # AX55.
l) ETHICON brand surgical device The product described on label is a: Trocar, Dilating Tip, 10/12 mm, 100 length w/stability sleeve,

Item # 512SD.
m) ETHICON brand surgical device. The product described on label is a: Trocar, Tristar, blunt tip, item 512B.
n) ETHICON brand surgical device. The product described on label is a: Scissors, curved with unipola 5 mm.
o) ETHICON brand surgical device The product described on label is a: Shears, Coagulating, item CS150.
p) ETHICON brand surgical device. The product described on label is a: Cutter, ETS Endoscopic Linear, 35 mm, item # TSB 35.
q) ETHICON brand surgical device. The product described on label is a: Clip Applier, Multiple MCA, 20 clips 9 3/8 inch, item # MCS 20.
r) ETHICON brand surgical device. The product described on label is a: Hook, Dissecting Harmonic Scalpel Blade 10 cm., item # DH105.
s) ETHICON brand surgical device The product described on label is a: Needle, 120 mm, Pneumopcritoneum, item # PN120.
t) ETHICON brand surgical device. The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012.
u) ETHICON brand surgical device. The product described on label is a: Cutter, Linear Vascular, Item # TSB-35.
v) ETHICON brand surgical device. The product described on label is a: Needle, Ultra Veress.
CODE All codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: International Surgical Supply, Inc., Miami, FL.
Manufacturer: MedSurg Solutions, Plymouth, MN.
REASON Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
VOLUME OF PRODUCT IN COMMERCE 1,355.
DISTRIBUTION MN and TN.

PRODUCT
a) Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
b) Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
CODE a) and b) Julian date coded "2003163".
RECALLING FIRM/MANUFACTURER Bausch & Lomb, Incorporated, Lynchburg, VA.

REASON The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
VOLUME OF PRODUCT IN COMMERCE 66 packs.
DISTRIBUTION FL, IA, WI, MA, IL and Internationally.

PRODUCT
a) Stanmore modular hip system; Stanmore CoCr femoral size 1 std. Stem; part 164241.
b) Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242.
c) Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243.
d) Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244.
e) Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245.
f) Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251.
g) Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252.
h) Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253.
i) Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254.
j) Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255.
CODE
a) Lots 323846, 342260, 352799, 377954, 404867, 434003, 442086, 442087, 442088, 448410, 469963, 469966;
b) Lots 382010, 402898, 447968, 453654, 490929;
c) Lots 293564, 379905, 381377, 382015, 393047, 425146, 426418, 470412, 470438, 471933;
d) Lots 255928, 269737, 300486, 326364, 331233, 349386, 378840, 381381, 386128, 389269, 389270, 422994, 429482, 429483, 429484, 429485, 429488, 429558, 445460, 449848, 449850, 449853, 449854;
e) Lots 197284, 211992, 211998, 225646, 226431, 233479, 233677, 251871, 255929, 266786, 269741, 279430, 286358, 292600, 292735, 326453, 336746;
f) Lots 267824, 292736, 336747, 348666, 351182, 351944, 358183, 361071, 366677, 375324, 376152, 396782, 424534, 424535, 438547, 469956, 497678, 095912;
g) lots 251875, 264803, 372966, 378842, 379914, 419755, 432703, 432704, 432706, 491077, 491081;
h) 230240, 267147, 286360, 299075, 322326, 336749, 336750, 353706, 375330, 376153, 377974, 381383, 384128, 386132, 430623, 430624, 431204, 432709, 447474, 449861, 506390;
i) Lots 233483, 233678, 247053, 257714, 266787, 267829, 284743, 299077, 325372, 336751, 356108, 366679, 377975, 381384, 389272, 426130, 431582, 434005, 458470, 469949, 492412, 503981, 505220;
j) Lots 216219, 225643, 226963, 245624, 251876, 257715, 269754, 275019, 288843, 325373, 336752, 365220, 378844.
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN.
REASON The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
VOLUME OF PRODUCT IN COMMERCE 231.
DISTRIBUTION Nationwide.

PRODUCT GE Medical Systems Corometrics Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is.
CODE All serial numbers are involved.
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, FL.
REASON The 2120 Main Board on device lacks required external safety "watchdog" circuit.
VOLUME OF PRODUCT IN COMMERCE 170.
DISTRIBUTION SC, WI, CA, MN, TX, MD, NV and France.

WEEK ENDING OCTOBER 18

Misys Healthcare Systems Issues Nationwide Recall of B-AUT-RAPID-LAB Software

Misys Healthcare Systems of Tucson, Ariz., is initiating a nationwide recall of the Misys Laboratory software versions 5.2, 5.23 and 5.3. In some instances, these particular versions of this software have demonstrated a defect that could result in inaccurate results being used in the diagnosis and/or treatment of a patient.

The recalled products have been distributed to health care facilities throughout the country. Misys Healthcare Systems is notifying its distributors and customers and strongly advising that the health care institutions using this product request the individual package B-AUT-RAPID-LAB Software version 5.3.3 as soon as possible.

Such requests should be made to the Misys Software Distribution Department or the health care institution’s client advocate at 1-877-239-6337.

PRODUCT CoaguChek brand PT Test Strips; U.S.

a) catalog number 3116247 (professional use);
b) 3116239 (patient self test); ex-U.S.

c) catalog numbers 1937642 (packaged 48 strips per box);

d) 1937634 (packaged 12 strips per box).
CODE
a) Lots 591;
b) Lot 619;
c) Lot 600; and
d) Lot 583. Extended to all lots with an expiration date of on or before March 1, 2005.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
VOLUME OF PRODUCT IN COMMERCE 563,628.
DISTRIBUTION Nationwide and Internationally.

PRODUCT BBL ™ LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
CODE Lot numbers: 3129508 exp 1/30/04; 3129509 exp 2/3/04; 3129506 exp 2/3/04; 3129512 exp 2/3/04.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Co., Sparks, MD.
REASON Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
VOLUME OF PRODUCT IN COMMERCE 860 cartons.
DISTRIBUTION Canada and Europe.

PRODUCT
a) CryoValve, Aortic & Conduit. Donor #69884, Model #AV00.
b) CryoValve, Pulmonary Valve & Conduit. Donor #69884, Model #PV00.
CODE
a) Serial #8062335;
b) Serial #8062341.
RECALLING FIRM/MANUFACTURER Cryolife Inc., Kennesaw, GA.
REASON Firm received additional information from the procurement agency indicating that the donor’s serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and MN.

PRODUCT Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
CODE All units.
RECALLING FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ.
REASON Version 2.6 software was released however, it will not properly handle adjustment slopes.
VOLUME OF PRODUCT IN COMMERCE 434 upgrades.
DISTRIBUTION Nationwide.

PRODUCT Neonatal GALT Test Kit, 4800 assays per kit, catalog No. NG-4100.
CODE Lot #164738.
RECALLING FIRM/MANUFACTURER PerkinElmer Life Sciences Inc., Norton, OH.
REASON The kits are producing lower values than expected, which may result in an increase of false positive test results.
VOLUME OF PRODUCT IN COMMERCE 79.
DISTRIBUTION AL, CT, AZ, CO, FL, IN, LA, MO, NJ, and OH.

PRODUCT Anti-dsDNA (1251) Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103.
CODE Lot Number 181578.
RECALLING FIRM/MANUFACTURER Perkinelmer Life Sciences, Inc., Boston, MA.
REASON Product’s outer carton label was labeled with an extended expiration date.
VOLUME OF PRODUCT IN COMMERCE 69 kits.
DISTRIBUTION CA, PA, IN, MO, and Switzerland.

PRODUCT On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464, Roche Diagnostics Label A305-02 Varian, Inc. label.
CODE All kits on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Varian, Inc., Lake Forest, CA.
REASON Stability in question.
VOLUME OF PRODUCT IN COMMERCE 11,847 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) Exactech Tibial Augmentation Block Trial Size 0, Tibial Augment block Trial, Catalog # 205-60-05, Tibial Augment Block Trial,

Catalog # 205-60-08;
b) Exactech Tibial Tray Trial size 1 Delta, Catalog # 201-70-81;
c) Exactech Trapezoid Tray Trial size 1 Delta, Catalog # 205-70-81.
CODE
a) Lot #’s 4786-001 and 6509-001, Lot #’s 4786-002 and 6509-002;
b) Lot #’s 4580-002, 6449-002 & 09861014;
c) Lot #’s 4603-002 & 6449-013.
RECALLING FIRM/MANUFACTURER Rxachech, Inc., Gainesville, FL.
REASON Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.
VOLUME OF PRODUCT IN COMMERCE 169.
DISTRIBUTION Nationwide, Spain, Japan and China.

PRODUCT Triton MP-1 Traction Unit. Model/Catalogue Nos.: 7961 (120 Volt) and 7963 (220 Volt).
CODE Serial Numbers: 4231 - 4246, 6806 - 6809, 6815, 6818 - 6819, 6824, 6851, 6856 - 6859, 6863, 6870 - 6873, 6878 - 6919, 6921 - 6958.
RECALLING FIRM/MANUFACTURER Chattanooga Corp., Hixson, TN.
REASON Product contains an improper bracket for the transducer.
VOLUME OF PRODUCT IN COMMERCE 96.
DISTRIBUTION Nationwide.

PRODUCT McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Brest Implant Saline Filled BIOCELL textured.
CODE 27-168391, 27-363170LF.
RECALLING FIRM/MANUFACTURER Inamed Corp, Goleta, CA.
REASON Labeling mix-up.
VOLUME OF PRODUCT IN COMMERCE 4 implants.
DISTRIBUTION TN.

PRODUCT Immulite 2000 H. pylori IgG Kit (L2KHQ6, 600 test size kit).
CODE Lot 118.
RECALLING FIRM/MANUFACTURER Diagnostic Products Corp., Los Angeles, CA.
REASON Kits had parts in them that did not belong in the kit.
VOLUME OF PRODUCT IN COMMERCE 339 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** (NOTE: product has an 18 month shelf life.)
b) Vitros Chemistry***GLU (glucose) DT Slides per box***CAT 153 2316*** (NOTE: product has a 24-month shelf life.)
CODE
a) All lots with an expiration date of 1 December 2004 and earlier.
b) All lots with an expiration date of 1 June 2005 and earlier.
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY.
REASON Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
VOLUME OF PRODUCT IN COMMERCE a) 487,912; b) 210,050.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.
CODE Lot No. 1278080, exp. date 5/2/2004.
RECALLING FIRM/MANUFACTURER Ciba Vision Corp, Duluth, GA.
REASON Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.
VOLUME OF PRODUCT IN COMMERCE 2,136 units.
DISTRIBUTION CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI.

PRODUCT Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
CODE Lot number 2290.
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, FL.
REASON Incorrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
VOLUME OF PRODUCT IN COMMERCE 235 cuffs in 47 cartons.
DISTRIBUTION Nationwide and Japan.

PRODUCT Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930, labeled in part: ***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00, Assembled in Mexico***.
CODE Lot 0601.
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, FL.
REASON Wrong connector attached to blood pressure cuff.
VOLUME OF PRODUCT IN COMMERCE 100.
DISTRIBUTION OR.

PRODUCT
a) Simplastin® L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553.
b) MDA® Simplastin® L, Product number 252555, 10 vials, 40 ml ea (400 test each).
CODE
a) Lot # 161642, 161643 and 161690;
b) Lot # 500065, 500066 and 500067.
RECALLING FIRM/MANUFACTURER BioMerieux, Durham, NC.
REASON Complaints of prolonged clot times.
VOLUME OF PRODUCT IN COMMERCE 1,546 units.
DISTRIBUTION Nationwide.

PRODUCT Quantum TTC Biliary Ballon Dilator.
CODE W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston-Salem, NC.
REASON The product was labeled ‘esophageal’, but contained a ‘biliary’ ballon.
VOLUME OF PRODUCT IN COMMERCE 127 devices.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING OCTOBER 25

PRODUCT Opti-Plast Balloon Dilatation Catheters.
CODE Models: XT75410, XT100410, XT120410.
RECALLING FIRM/MANUFACTURER Bard Peripheral Vascular, Tempe, AZ.
REASON Product intended for distribution outside USA was distributed without pre-market notification requirements being met.
VOLUME OF PRODUCT IN COMMERCE 14.
DISTRIBUTION OH, AL, MS, LA, and VA.

PRODUCT Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
CODE S/Ns: 0001 to 2005, and S/Ns: 2172 to 2885.
RECALLING FIRM/MANUFACTURER Rultract Inc., Independence, OH.

REASON Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
VOLUME OF PRODUCT IN COMMERCE 2,718.
DISTRIBUTION Nationwide.

PRODUCT Urology X-Ray System, Hardware for Motor Drive.
CODE Uroskop D1/D2/D3.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA.
REASON Possible movement of table tilt and table longitudinal.
VOLUME OF PRODUCT IN COMMERCE 34 units.
DISTRIBUTION Nationwide.

PRODUCT Conquest Ballon Dilation Catheters Model/Catalog Number CQ 75124.
CODE Lot 93DN0081.
RECALLING FIRM/MANUFACTURER Bard Peripheral Vascular, Tempe, AZ.
REASON Mislabeled. 7mm balloon labeled 12mm.
VOLUME OF PRODUCT IN COMMERCE 124.
DISTRIBUTION Nationwide.

PRODUCT Power cord manufactured by ElectriCord Manufacturing Company, P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

CODE Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, FL.
REASON Reports of broken plug ground pins on AC power cords for patient monitors.
VOLUME OF PRODUCT IN COMMERCE 17,006.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
CODE All units with current software versions (v 06-06 and 07-01).
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted.
VOLUME OF PRODUCT IN COMMERCE 478.
DISTRIBUTION Nationwide.

PRODUCT
a) Critikon brand Omni-Stat Finger Sensor - P/N 009084.
b) Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130.
c) Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136.
CODE
a) Lot 006;
b) Lot numbers 008 and 005;
c) Lot 3910.
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, Fl.
REASON Instructions for use contained incorrect sensor reference.
VOLUME OF PRODUCT IN COMMERCE 481.
DISTRIBUTION Nationwide and Internationally.

PRODUCT TC-PLUS Solution Tibial Component-Symmetric.
CODE Lot 0211.13.4553.
RECALLING FIRM/MANUFACTURER Plus Endoprothetik AG, Rotkreuz, China.
REASON Labeling/packaging mix-up.
VOLUME OF PRODUCT IN COMMERCE 15.
DISTRIBUTION TX, CA, VA, ID, NY, UT, and FL.

PRODUCT CryoValve, Pulmonary Valve & Conduit SG.
CODE Donor #61354, Device #7693941, Model #SGPV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON The heart valve procurement exceeded the warm ischemic time criteria.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040.
b) Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan.Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
c) HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160.
d) HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R.
e) Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge
f) Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Disposable (single use only), sterile, latex free. Catalog # 55050.
CODE
a) Lots 50905127 and 50905036;
b) Lots 50904840, 50904918, 50904919, 50904935, 50904958, 50904959, 50904988, 50904994, 50905033, 50905050A, 50905093, 50905121 and 50905148;
c) Lots 50904972 and 50905039;
d) Lots 50904954, 50905019 and 50905099;
e) Lots 994985, 994986 and 995044;
f) Lots 50904971 and 50905123.
RECALLING FIRM/MANUFACTURER Vital Concepts, Inc., Grand Rapids, MI.
REASON The suction valve may become stuck in the 'suction on' position under vacuum.
VOLUME OF PRODUCT IN COMMERCE 3,355.
DISTRIBUTION Nationwide, Canada, Israel and Japan.

PRODUCT Lactate Disposable Membrane Caps Product Number: 0018108400.
CODE US Distribution Lot Numbers: N307, Exp. 1/30/04 N30601, Exp. 12/30/03; International Distribution: N30301 Exp. 9/30/03 N30501 Exp. 11/30/03 N306 Exp 12/30/03 N30604 Exp. 12/30/03 N308 Exp. 2/28/04.
RECALLING FIRM/MANUFACTURER Instrumentation Laboratory Co., Lexington, MA.
REASON Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
VOLUME OF PRODUCT IN COMMERCE 287 boxes.
DISTRIBUTION IL, NY, Italy and Mexico.

PRODUCT Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
CODE All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp, Indianapolis, IN.
REASON Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
VOLUME OF PRODUCT IN COMMERCE 42,887.
DISTRIBUTION Nationwide, Canada and Germany.

PRODUCT
a) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011.
b) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051.
c) Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1cm Tip 20 mm Balloon,Catalog Number H74903628151

CODE
a) Lot 5689062;
b) Lots 5685024 and 5685027;
c) Lot 5707453.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN.
REASON Some of the recalled catheters have a component that has levels of pyrogens above specification.
VOLUME OF PRODUCT IN COMMERCE 16 catheters.
DISTRIBUTION Nationwide.

PRODUCT
a) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; 20 units per case; reorder #BLD-83124-2.
b) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; 20 units per case; reorder #BLD-83100-24.
c) Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; 20 units per case; reorder #BLD-83144-24.
d) Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; 20 units per case; reorder #BLD-83120.
e) Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; 20 units per case; reorder #BLD-83166.
f) Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow and O2 supply tubing; 20 units per case; reorder #BLD-83167.
CODE
a) Lot 11409;
b) Lots 11394 and 11680;
c) Lot 11679;
d) Lot 11593;
e) Lot 11384;
f) Lots 11385 and 11541.
RECALLING FIRM/MANUFACTURER VIASYS Med Systems, Wheeling, IL.
REASON The exhalation hole in the side-port relief valve may be blocked, allowing excess pressure build-up.
VOLUME OF PRODUCT IN COMMERCE 5,540 units.
DISTRIBUTION Nationwide.

PRODUCT Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent.
CODE Lot 758031F1, Part number 6607073.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Package insert contains inaccurate information.
VOLUME OF PRODUCT IN COMMERCE 233.
DISTRIBUTION Nationwide

PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.)
CODE Versons 6.0 through 6.4.1 (excluding version 6.3.8).
RECALLING FIRM/MANUFACTURER Olympus America Inc., Melville, NY.
REASON Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
VOLUME OF PRODUCT IN COMMERCE 1,014.
DISTRIBUTION Nationwide, Puerto Rico, Canada, Mexico, Ecuador and Chile.

PRODUCT T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
CODE Lot K884459.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON The device does not have an oblong hole for dynamic locking as required.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION PA, VA, GA, KS, and CA.

PRODUCT
a) Liberty brand Insulin Syringes for use with U-100 insulin, ‡ cc X 30G X 5/16" syringes.
b) Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X ‡" insulin syringes.
c) Liberty brand Insulin Syringes for use with U-100 insulin, ‡ cc X 29G X ‡" insulin syringes.

CODE
a) Lot # 2IE03;
b) Lot # 2HC02;
c) Lot # 21A03.
RECALLING FIRM/MANUFACTURER Liberty Medical Supplies, Port Saint Lucie, FL.
REASON The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box.
VOLUME OF PRODUCT IN COMMERCE 1,880 cases (100 syringes).
DISTRIBUTION Nationwide.

PRODUCT McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401, 25-40461, 25-40501, 25-40561.
CODE Serial numbers are too numerous to include.
RECALLING FIRM/MANUFACTURER Inamed Corp, Goleta, CA.
REASON The 400cc, 460cc, 500cc 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells that required.
VOLUME OF PRODUCT IN COMMERCE 694.
DISTRIBUTION Nationwide and Canada.

PRODUCT Acticoat* Moisture Control Dressing, Product Code 20211.
CODE 021022A, 021023A, 021118A, 030106A, 030107A.
RECALLING FIRM/MANUFACTURER Smith and Nephew, Inc., Wound Management Division, Largo, FL.
REASON Product may not meet the established stability specification before the end of labeled expiry date.
VOLUME OF PRODUCT IN COMMERCE 3,355.
DISTRIBUTION Nationwide.