JULY 2002

WEEK ENDING JULY 6

PRODUCT Axiom Artis Angiographic X-Ray

CODE Siemens part #:5904433.

RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ

Manufacturer: Siemens AG, Medical Solutions, Erlangen, Germany.

REASON System Database damage, last and future images not saved.

VOLUME OF PRODUCT IN COMMERCE 15 units.

DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Varian Medical System's Eclipse VERSION 6.5 software, a proprietary application for Varian Vision (tm) imaging systems.

CODE Eclipse software, version 6.5, Serial Numbers: 0016, 0018, 0022, 0034, 0044, 0045, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0068, 0069, 0107, 0108, 0119, 0133, 0134, 0135, 0138, 0139, 0148, 0149, 0150, 0181, 0187, , 188, 0189, 0210, 0212, 0213, 0243, 0248,

0249.

RECALLING FIRM/MANUFACTURER Recalling Firm: Varian Medical Systems, Inc., Palo Alto, CA

Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA.

REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen.

VOLUME OF PRODUCT IN COMMERCE 37 units.

DISTRIBUTION AL, GA, IN, KY, MS, MI, and NY and Japan.

PRODUCT Information Center System and Upgrades as follows:

a) M3150A Agilent or Virida Information center.

b) M3151A Agilent or Virida Information Center Client.

c) M3153A Agilent or Virida Surveillance Center.

d) M3150AU#A01 Agilent or Virida Information Center Upgrade.

CODE Systems distributed with a Hewlett Packard Vectra VL400 Personal Computer(PC),HP Part# P3715W with the following serial numbers:

US10204040 through US10710329

US10811665 through US10811789

US10902444

US10902817 through US10902887

US11304210

US11304576 through US11304670

US11307358

US11307974 through US11500994

US11608246

US11608393 through US11703817

US11704443

US11709038 through US11709052

US11800005

US11800291 through US11904733

US12104028

US12104584 through US12104621

US12106958

US12107167 through US12107365

US12203988

US12203996 through US12204354

US12210341

US12210494 through US12210535

US12210537

US12210539 through US12210575

US12210579

US12210581

US12210583 through US12210622

US12403504

US12403528 through US12408065

US12408067

US12408070 through US12408085

US12608928

US12609515 through US12609752

US12609757 through US12609883

US12618799

US12618806 through US12618807

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems, formerly Agilent Technologies, Andover, MA

Manufacturer: Philips Medical Systems, Andover, MA.

REASON Central Station Monitor may have a premature hard drive failure causing the unit to shut down.

VOLUME OF PRODUCT IN COMMERCE 2,296.

DISTRIBUTION Nationwide.

PRODUCT Syncor PharmaSeed BT-125-1, radioactive iodine-125 brachytherapy source.

CODE Model BT-125-1, Lot Numbers I125G-0567, I125G-0568, I125G-0583, I125G-0584, I125G-0585.

RECALLING FIRM/MANUFACTURER Syncor Pharmaceuticals, Inc., Golden, CO

REASON Seeds may not meet established internal criteria for radial dose uniformity.

VOLUME OF PRODUCT IN COMMERCE 5 lots.

DISTRIBUTION GA and MD.

WEEK ENDING JULY 13

PRODUCT Breathing bag and the bleed valve assemblies, as follows:

a) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 2L. Part no. 4312

b) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L [with Norman mask elbow and Washington tee]. Part no. 15609.

c) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L. [with Norman mask elbow, Washington tee and an extra gas sampling line]. Part no. 15609A.

d) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L, [with Norman mask elbow]. Part no. 4322-30.

e) MMS (Meridian Medical Systems) brand Modified Jackson Rees, latex-free, 2L. Part no. 4222-30.

f) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1L. Part nos. 4311 and 4321

g) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 1L. Part no. 4321-30

h) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 1/2L. Part No. 4325-30-50.

i) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees. Part no. 4211

j) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees., 1L bag [with fresh gas elbow]. Part no. KS4160

k) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag [with fresh gas elbow]. Part no. KS4180

l) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1/2L bag. Part no. KS4230

m) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1L bag. Part no. KS4610

n) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag. Part no. KS4630

o) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag and an extra 72 inch hose. Part no. KS4830

p) Meridian Medical Systems brand Circuit-Modified Jackson Rees. latex-free, 1L bag. Part no. 4221-30

q) Hudson Respiratory Care brand anesthesia breathing circuit, modified Jackson-Rees Circuit, .5 liter bag w/valve. Cat. No. 354006

r) Hudson Respiratory Care brand anesthesia breathing circuit, modified Jackson-Rees Circuit, 1 liter bag w/valve. Cat. No 354007

s) Hudson Respiratory Care brand breathing circuit, nonconductive modified Jackson-Rees (with Norman fresh gas elbow and gas scavenging valve), 3L. Cat. no. 7145

t) MMS (Meridian Medical Systems) brand breathing bag- 1L latex w/bleed valve. Part no. 3501-36B

u) MMS (Meridian Medical Systems) brand breathing bag w/bleed valve, latex-free, 1/2L bag. Part No. 3525-36B30

v) Trident Medical International brand breathing bag with bleed valve-2L, latex-free. Ref. no. T3522-36B30.

w) Trident Medical International brand circuit-MJR, 1L bag. Ref. no. T4211.

x) Trident Medical International brand circuit-MJR, latex-free, .5L bag. Ref. no. T4315-30.

y) Trident Medical International brand circuit-MJR, latex-free, 1L bag. Ref. no. T4311-30.

z) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 3L bag. Part no. AC15479.

aa) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 2L bags. Part nos. AC16112

bb) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 2L bags [with Washington T and 72 inch fresh gas line]. Part no. AC4222.

cc) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 1L bag [and an extra 100 inch hose]. Part no. AC4312.

dd) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 3L. Part no. AC15479.

ee) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees. Part no. AC16112 and AC4222.

ff) A+CC (Anesthesia & Critical Care Products) brand circuit-modified Jackson Rees, 2L bag [with extra 100 inch hose]. Part no. AC4312.

gg) Anesthesia Service Inc. brand circuit-modified Jackson Rees, 3L bag. Part no. ASI4213.

hh) DRE (DRE Medical) brand circuit- modified Jackson Ree, 1L bag. Part No. DRE4321.

ii) DRE (DRE Medical) brand circuit- modified Jackson Rees, .5L bag. Part No. DRE4325.

jj) Metro (Metropolitan Medical Inc.) brand circuit- modified Jackson Rees, 3L bag. Part No. MMI4323.

CODE all lots manufactured between 9/1/00 thru 10/30/01.

Part 15609; lots 193830900, 196110900, 199631000 and 208261000

Part 15609A; lots 190180800, 190540800 and 204391000

Part 4222-30; lot 209031000

Part 4311; lot 277640601

Part 4321; lots 224661200, 255090301 and 298640801

Part KS4160; lot 298240801

Part KS4180; lot 309301001

Part KS4230; lot 296270801

Part KS4610; lots 302110901 and 298960801

Part KS4630; lot 313441001

Part KS4830; lot 223551200

Part 4312; lot 199761000

Part 4211; lot 233270101

Part 4221-30; lot 221101200

Part 4322-30; lots 191510801, 193580800, 197500900, 203491000, 212131100, 209661100, 211841100, 215021100, 219691200, 221831200, 236210101, 224680101, 253190301, 257750401, 242950201, 267520501, 267810501, 282990601, 286070701, 292150701, 295180801, 295950801, 299790801, 301810901, 305680901, 308440901, 313541001, 311781001 and 315831001

Part 4325-30-50; lots 191520800, 194150900, 197510900, 202751000, 203501000, 212141100, 215031100, 222391200, 224691200, 224701200, 226800101, 233470101, 254130301, 269070501, 264460404, 261040401, 274120501, 283000601, 290050701, 301820901, 309461001 and 314371001

Part 4321-30; lots 191950800, 194140900, 195810900, 197490900, 199771000, 203481000, 209651100, 211831100, 212121100, 215011100, 219681200, 218211100, 224671200, 226780101, 233460101, 236200101, 241250201, 242940201, 248050301, 254120301, 263010401, 267800601, 269060501, 258980401, 264450401, 274110501, 282980601, 285570701, 287440701, 287420701, 288760701, 292140701, 295170801, 297040801, 299780801, 301800901, 305220901, 310461001, 307380901, 311771001 and 313531001

Part 354006; lots 196580900, 201441000, 228720101, 258210401, 306510901, 307180901 and 309051001

Part 354007; lots 185590700, 183780700, 190300800, 201451000, 225641200, 229740101, 278130601, 297750801, 297790801 and 306520901

Part 7145; lots 185170700, 185560700, 191300800, 201941000, 306590901 and 308500901

Part 3501-36B; lot 294750801

Part 3525-36B30; lots 259800401, 266030501, 262210401, 268990501, 282810601, 297270801, 303290901 and 308410901

Part T3522-36B30; lot 301360900

Part T4211; lots 285890701 and 312130700

Part T4311-30; lots 193490800 and 196060900

Part T4315-30; lot 50390301

Part AC15479; lots 221371200, 221381200, 212761100, 208771000, 220041200 and 267720501

Part AC16112; lots 306190901 and 192870800

Part AC4222; lot 192830800, 197580900, 197760900, 211711100 and 310251001

Part AC4312; lot 302060901

Part ASI4213; lots 201991000, 206601000, 210941100, 234730101 and 244570201

Part DRE4321; lot 231020101

Part DRE4325; lot 228500101 and 2310301010

Part MMI4323; lot 310641001.

RECALLING FIRM/MANUFACTURER Meridian Medical Systems, Inc., Indianapolis, IN

REASON A rubber breathing bag tip may be inside of the breathing bag.

VOLUME OF PRODUCT IN COMMERCE 734 cases (20 bags per case).

DISTRIBUTION CA, CO, FL, IN, KS, KY, MO, OK, OR, PA and VA.

PRODUCT CryoValve Allograft - Heart valve

CODE Serial No. 6773739, Model No. PV00.

RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA

REASON Aortic valve donor was associated with alleged case of Endocarditis.

VOLUME OF PRODUCT IN COMMERCE One valve.

DISTRIBUTION CA.

PRODUCT Depuy brand self-centering bi-polar head, 28MM ID, 45 MM OD

CODE Part 1035-45-000, lot WB1DR1.

RECALLING FIRM/MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, IN

REASON Incorrect components included in two packages from this lot.

VOLUME OF PRODUCT IN COMMERCE 2.

DISTRIBUTION NJ and PA.

WEEK ENDING JULY 20

PRODUCT LTV Series Ventilators LTV 1000, Catalog No. 10130; LTV 950, Cat. No. 10950; LTV 900, Cat. No. 10638; LTV 800, Cat. No. 11800

CODE Unavailable at this time.

RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Colton, CA

REASON Capacitor malfunction leading to quit with no alarm.

VOLUME OF PRODUCT IN COMMERCE 3,348.

DISTRIBUTION Nationwide and Internationally.

PRODUCT Fresenius brand Hemodialysis Delivery Systems, Model 2008K Software version 2.12.

CODE Model 2008K.

RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius Medical Care North America, Dialysis Product Division, Walnut Creek, CA

REASON Firm has received reports of excessive ultrafiltration.

VOLUME OF PRODUCT IN COMMERCE 4,829 units.

DISTRIBUTION Nationwide.

PRODUCT Silicone Double Lumen Hemo Cath Kit. Each kit contains a Lidocaine HCl 1%, 5 cc ampule.

CODE Catalog Number MCDLTSL28. Kit Lot number M929970 exp 5/02.

RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA

REASON Kit contains expired drug component.

VOLUME OF PRODUCT IN COMMERCE 250 kits.

DISTRIBUTION Nationwide.

WEEK ENDING JULY 27

PRODUCT a) EasyVision CT/MR Release 2 Model Numbers: 9896-010-1336x and 9896-010-1338x where x= 1,2, or 3.

b) EasyVision Release 4 Model Number: 9896-050-0961; 9896-050-00921, 9896-050-03651.

CODE All units of the model numbers listed.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Shelton, CT

Manufacturer: Philips Medical System, Nederlands, BV Best.

REASON Transferred Image Data may result in the reversal of Left/Right Indicators.

VOLUME OF PRODUCT IN COMMERCE 65 units Easy Vison Rel 2; 118 units EasyVision Rel 4.

DISTRIBUTION Nationwide.