JUNE 2004

WEEK ENDING JUNE 5

PRODUCT Minstrel Patient Lift; a non-AC-powered patient lift; model numbers HMB001-US and HMB002-US (with scale).
CODE All units with and without scales up to and including serial number MPLAT0307W855.
RECALLING FIRM/MANUFACTURER Arjo, Inc., Roselle, IL.
REASON The hanger bar may detach from the jib yoke, and the M8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.
VOLUME OF PRODUCT IN COMMERCE 112 units.
DISTRIBUTION Nationwide.

PRODUCT Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
CODE Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708.
RECALLING FIRM/MANUFACTURER Eastman Kodak Co., Rochester, NY.
REASON Defective component in overhead tube support balancer may cause the suspended load to fall.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Amsterdam, China, and Kuwait.

PRODUCT Xcelera System, image processing, radiological.
CODE Part numbers: 9896 050 73251XC1.1L1, Software binder: 9896 050 73252XC1.1L1 Software binder + SP2.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales & Service Region No. America, Bothell, WA.
REASON Potential for the image data to be erased from the long term archive.
VOLUME OF PRODUCT IN COMMERCE 56 units.
DISTRIBUTION Nationwide.

PRODUCT VersaRad/Traumex General Radiographic System.
CODE All units.
RECALLING FIRM/MANUFACTURER Fischer Imaging Corp., Denver, CO.
REASON Two of the four T-nuts that connect the transverse rail to the "U" arm and transverse rails could fall and cause serious injury.
VOLUME OF PRODUCT IN COMMERCE 138 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Customized Automation Centrifuge, First and Second Generation.
CODE

First Generation: OPIC0004, HAND0007, HAND0008, HAND0011, HAND0012, U9507151, U9507152, U9507153. Second Generation: 2028, 2030, 2032, 2033, 2034, 2038, 2039, 2040.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION Nationwide.

PRODUCT VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series.
CODE Config ID/Serial# (Domestic) ACC01220 VS00014 VS00015 VS00016 VS00017 VS00025 VS00028 VS00029 VS00034 VS00036 VS00037 VS00045 VS00047 VS00048 VS00049 VS00050 VS00051 VS00052 VS00053 VS00054 VS00055 VS00058 VS00064 VS00065 VS00066 VS00067 VS00068 VS00070 VS00072 VS00075 VS00076 VS00077 VS00078 VS00082 VS00083 VS00084 VS00085 VS00086 VS00089 VS00095 VS00204 VS00205 VS00207 VS00208 VS00209 VS00210 VS00212 VS00214 VS00215 VS00217 VS00219 VS00220 VS00221 VS00222 VS00223 VS00225 VS00226 VS00227 VS00230 VS00231 VS00232 VS00233 VS00234 VS00236 VS00237 VS00238 VS00243 VS00245 VS00246 VS00251 VS00253 VS00255 VS00256 VS00257 VS00258 VS00261 VS00262 VS00265 VS00266 VS00268 VS00271 VS00276 VS00281 VS00282 VS00283 VS00286 VS00287 VS00288 VS00289 VS00292 VS00296 VS00298 VS00299 VS00300 VS00300-1 VS00302 VS00303 VS00304 VS00305 VS00306 VS00307 VS00309 VS00310 VS00311 VS00314 VS00315 VS00316 VS00317 VS00318 VS00319 VS00320 VS00321 VS00322 VS00323 VS00325 VS00326 VS00327 VS00328 VS00329 VS00330 VS00331 VS00332 VS00333 VS00334 VS00336 VS00337 VS00340 VS00341 VS00342 VS00343 VS00344 VS00345 VS00347 VS00348 VS00349 VS00350 VS00352 VS00355 VS3184177491000 VS3184191051000 VS3184610861000 VSBASSETT VSSTBERNADINESS VSSTOCK.
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Charlottesville, VA.
REASON Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners. Excessive turning of the hand wheel on VariSource 200, 200t and ID model afterloaders when the active wire is parked can cause the active wire to become dislodged from the shielding.
VOLUME OF PRODUCT IN COMMERCE 249 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube.
b) Exacta-Mix Valve Set, Secondary Valve Assembly.
c) Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembly.
d) Exacta-Mix Valve Set, Six Inlet, Tubing Kit.

e) Exacta-Mix Valve Set, Primary Valve Assembly.

f) Exacta-Mix Valve Set, Primary Valve Assembly. Pediatric.
g) Exacta-Mix Valve Set, Primary Valve Assembly.
CODE
a) Order No. REF: 69;
b) Order No. REF: 693;
c) Order No. REF: 706;
d) Order No. REF: 706D;
e) Order No. REF: 711E;
f) Order No. REF: 712E;
g) Order No. REF: 713.
RECALLING FIRM/MANUFACTURER Baxa Corp., Englewood, CO.
REASON A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
VOLUME OF PRODUCT IN COMMERCE 3,160 cases.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Mentor Smooth Round Becker 50 Expander, dome part number 350-DOMPK.
CODE Lot numbers 269402 and 264358.
RECALLING FIRM/MANUFACTURER Mentor Texas, Inc., Irving, TX.
REASON Device was distributed without the dome part accessory.
VOLUME OF PRODUCT IN COMMERCE 51 units.
DISTRIBUTION Nationwide.

WEEK ENDING JUNE 12

PRODUCT STS-T Mobile X-Ray System.
CODE No codes.
RECALLING FIRM/MANUFACTURER Medstone International Inc., Aliso Viejo, CA.
REASON The identification and certification labels were inadequate or missing.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION Nationwide.

PRODUCT Laser System, model CNI GLP-III green laser pointer. Use for industrial, scientific and research purposes.
CODE No codes.
RECALLING FIRM/MANUFACTURER Changchun New Industries Optoelectronics Tech, Co., Ltd., Changchun, China.
REASON The laser product was found to be noncompliant with the laser product report.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION WA, CA, and MN.

PRODUCT Coulter AcT 5diff Autoloader (AL) Hematology Analyzer.
CODE All software versions (1.00 & 1.20).
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Software anomaly causes sample results to be not credible, reported as ì0î or left blank. The next sample will also be incorrectly reported for the same parameter.
VOLUME OF PRODUCT IN COMMERCE 71
DISTRIBUTION Nationwide and Canada.

PRODUCT
a) Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142.
b) FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143.
CODE
a) Lot numbers: 7848, 7849, 7850, 7853, 7854, 7855, 7857, 7858, 7859, 7860, 7861, 7863, 7866, 7867, 7868, 7870,
7871, 7872, and 7874;
b) Lot numbers: 7851, 7852, and 7856.
RECALLING FIRM/MANUFACTURER Cardiac Science, Inc., Irvine, CA.
REASON Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
VOLUME OF PRODUCT IN COMMERCE 4,730 batteries.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Compounding Brochure titled ìNutrition Compounding Simplifiedî, Lit #800415, print date January 2002; the
brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High
Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L;
b) Micromix Compounder Implementation Guide; this guide is distributed by Professional Services as part of the
training classes for new Micromix Compounder customers.
CODE
a) Lit #800415, print date January 2002 This brochure was distributed individually and as part of the Baxter Info
Quick Card (on CD-Rom), versions Q4 2003 and Q2 2003;
b) Pages 60 and 61 of the guide.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON The promotional material for the Automix/Accusource and
Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.
VOLUME OF PRODUCT IN COMMERCE 1,366 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials.
CODE Lots MX249N and MX249H of ABX Diagnostics Minotrol 16 Controls, Normal and High; and Lots 040308ND and 040308HD of Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High.
RECALLING FIRM/MANUFACTURER R & D Systems, Inc., Minneapolis, MN.
REASON Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing.
VOLUME OF PRODUCT IN COMMERCE 29,494 vials of the normal controls and 15,196 vials of the high controls.
DISTRIBUTION CA, France, and Japan.

PRODUCT Fuji Flash IIP and CR-IR346CL Consoles.
CODE Versions A09-17 through A11-12.
RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT.
REASON Software: Incorrect measurement of objects within a CR image.
VOLUME OF PRODUCT IN COMMERCE 2,602 units.
DISTRIBUTION Nationwide.

PRODUCT T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
CODE Lot Code: K589039; K658262; K658259; K74990; K766542.
RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Mahwah, NJ.
REASON Targeting device may become distorted upon repeated autoclaving.
VOLUME OF PRODUCT IN COMMERCE 32 devices.
DISTRIBUTION Nationwide.

WEEK ENDING JUNE 19

PRODUCT LuMend brand percutaneous catheter .35" R in plastic sealed bag, sterilized with ethylene oxide gas. CODE Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
RECALLING FIRM/MANUFACTURER Lumend Inc, Redwood City, CA.
REASON Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
VOLUME OF PRODUCT IN COMMERCE 117 catheters.
DISTRIBUTION Nationwide.

PRODUCT AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
CODE Lot # 0584B.
RECALLING FIRM/MANUFACTURER Acist Medical Systems, Eden Prairie, MN.
REASON Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 3590 kits.
DISTRIBUTION Nationwide.

PRODUCT Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W.
CODE Serial Numbers: SE15704205, SE16773210, and SE16935305.
RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc, Twinsburg, OH.

REASON Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in misdiagnosis and delay in treatment.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH, PA, and WI.

PRODUCT Quickcable Autoclaveable Cable Electrode Cable.
CODE Lot 005955.
RECALLING FIRM/MANUFACTURER Biosense Webster, Inc., Irwindale, CA.
REASON Mislabeling.
VOLUME OF PRODUCT IN COMMERCE 212.
DISTRIBUTION Nationwide, Australia, Korea, Chile, Brazil.

PRODUCT
a) Ultraview Universal Clinical Workstation Model 90385.
b) Ultraview 1700 Monitor Model 90387.
CODE
a) Serial numbers 385-3xxxxx or higher;
b) Serial numbers 387-1xxxxx or higher.
RECALLING FIRM/MANUFACTURER Spacelabs Medical, Issaquah, WA.
REASON Potential for telemetry channels to drop off display.
VOLUME OF PRODUCT IN COMMERCE 1,792 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt. Catalog # 027770201.
CODE Lot # 0406800015.
RECALLING FIRM/MANUFACTURER Cobe Cardiovascular, Inc , Arvada, CO.
REASON Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
VOLUME OF PRODUCT IN COMMERCE 216 sets.
DISTRIBUTION Nationwide and Canada.

PRODUCT
a) HomeChoice and Yume Automated Peritoneal Dialysis Systems; catalog numbers 5C4471, 5C4471R, 5C4474,
5C4474R, T5C4441, T5C4441R.

b) HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; catalog numbers 5C8310, 5C8310R,
R5C8320, R5C8320R, T5C8300, T5C8300R.

CODE a) and b) All HomeChoice Systems with software versions 8.5 and higher.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div, Mc Gaw Park, IL.
REASON A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.
VOLUME OF PRODUCT IN COMMERCE 17,026 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to convert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
CODE No serial numbers but the Dinalink protocol converter and cable has the product identifier of "LC1931".
RECALLING FIRM/MANUFACTURER GE Medical Systems Information Technologies, Tampa, FL, by letter on January 27, 2004. Firm initiated recall is complete.
REASON The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
VOLUME OF PRODUCT IN COMMERCE 36.
DISTRIBUTION PA, SC, GA, FL, WI, SD AND WY.

PRODUCT
a) Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070.

b) Portex Inner Cannula for Tracheostomy Tube size 8.0 mm, REF Code 566080.
CODE All lot numbers.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc, Keene, NH.
REASON Incompatible products may cause potential trachea trauma.
VOLUME OF PRODUCT IN COMMERCE 85,800.
DISTRIBUTION Nationwide.

PRODUCT Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only.
CODE Reorder/Catalog Number: NJFT-1-ML, Lot #1803299, Expiration Date: 09-2008.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc, Winston Salem, SC.
REASON The nasal transfer tube may be missing from the package of the affected lot.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION NC, Ireland & Poland.

PRODUCT M/DN Intramedullary Fixation Humeral Nail. Catalog no. 00-2254-195-09.
CODE Lot # 20118000.
RECALLING FIRM/MANUFACTURER Zimmer Inc. Warsaw, IN.
REASON One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Catalog number 324-01-106.
b) 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Catalog number 333-02-106;

CODE
a) Lot number 991151;
b) Lot numbers 991141 and 991131.
RECALLING FIRM/MANUFACTURER Encore Medical, LP, Austin, TX.
REASON Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE.
VOLUME OF PRODUCT IN COMMERCE 31.
DISTRIBUTION IA, MA, OK, TX, FL, CA, and SD and Germany.

WEEK ENDING JUNE 26

Tecan US Issues Nationwide Voluntary Recall of Tecan Clinical Workstation

Tecan US, Research Triangle Park, North Carolina today announced a voluntary recall to make field corrections for Tecan Clinical Workstations. The Tecan Clinical Workstations (TCW) have been found to mismatch patient identification and test results in some cases. The workstations are used to test for gonorrhea, Chlamydia and drug abuse.

The voluntary recall includes the Tecan Clinical Workstation and no other models or software of the Tecan products. Tecan US distributed the Tecan Clinical Workstation in the US through direct sales and distributors.

Tecan US notified distributors and customers that if an operator of the TCW fails to purge the TCW’s data management system on a regular basis, in accordance with the TCW’s operating instructions, the TCW’s software might mismatch sample results and sample identification. Tecan and the distributors of TCW initiated a field corrective action that included asking customers to perform a purge of their data on a monthly basis. Again, to Tecan’s knowledge, in all reported cases the error was noticed before results were reported out and no patient results were adversely affected.

Further, Tecan US identified the root cause of known occurrences with mismatched merging of sample identification and sample result using the TCW software and issued a retrofit of software (version 5.1.1) for the TCW to assure that results are not affected.

Laboratory customers who need to review the field correction action may contact Tecan Technical Support at 1-800-352-5128.

Patients who are concerned about the results of a test performed on the TCW should consult their physician. Tecan US will continue to work closely with the FDA, TCW distributors and TCW customers to alert facilities against mismatched sample identification.

PRODUCT COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
CODE All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp, Indianapolis, IN.
REASON The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION CA, CT, IL, MA, PA, TX and WI.

PRODUCT Tecan Clinical Workstations with Robonet software.
CODE PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
RECALLING FIRM/MANUFACTURER Tecan US Inc., Durham, NC.
REASON Tecan software has the potential to match the patient with a different patientís test results.
VOLUME OF PRODUCT IN COMMERCE 44 units (Hardware), 33 units (Software).
DISTRIBUTION Nationwide.

PRODUCT X-ray systems, model numbers: P200R24 and P200R40.
CODE None supplied.
RECALLING FIRM/MANUFACTURER MinXray, Inc., Northbrook, IL.
REASON The units user manual had missing or inadequate information.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.

PRODUCT Radionics Head and Neck Localizer (HNL), Version B.
CODE Serial Numbers: 032610023, 0326100023, 32690010, 041200023.
RECALLING FIRM/MANUFACTURER Radionics, Inc., Burlington, MA.
REASON Software may provide inaccurate coordinates and cause mistreatment.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Canada, Germany, and Greece.

PRODUCT Cardio Respiratory Monitor with Oximax technology with software version 5.0, Model 511.
CODE Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through 0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through 0414477.
RECALLING FIRM/MANUFACTURER CAS Medical Systems, Inc., Branford, CT.
REASON Device may not alarm for %SpO2 value limit violations if a specific feature is enabled.
VOLUME OF PRODUCT IN COMMERCE 146 units.
DISTRIBUTION Nationwide, Canada, and Taiwan.

PRODUCT NC Stormer Zipper MX Balloon Dilation Catheter, a Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
CODE Not supplied.
RECALLING FIRM/MANUFACTURER Medtronic Vascular, Santa Rosa, CA.
REASON Medical device for which sterility may be compromised because of improper seal.
VOLUME OF PRODUCT IN COMMERCE 193 units.
DISTRIBUTION Nationwide.

PRODUCT Hitachi Ascension PIP instrument tray base. .
CODE All trays in the marketplace at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Ascension Orthopedics, Inc., Austin, TX.
REASON Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
VOLUME OF PRODUCT IN COMMERCE 107 trays.
DISTRIBUTION Nationwide.

PRODUCT Synchron Systems Acetaminophen Reagent, part No. 472169.
CODE All lots.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Firm shortened calibration frequency to 7 days from 14 days.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide and Canada.

PRODUCT DL 2000 Data Manager.
CODE Version 6.2.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
VOLUME OF PRODUCT IN COMMERCE 231 units.
DISTRIBUTION Nationwide.

PRODUCT Trolley for Intera/NT MRI System.
CODE
The firm uses site numbers instead of serial numbers: Site Numbers: 105313, 104340, 105929, 84700, 103811, 103904, 504899, 102157, 103592, 85500, 87355, 86404, 103247, 87604, 505682, X1595, 101595, 87062, 103215, 86012, 103620, 101070, 104897, 105486, 83306, 86184, 100826, 84899, 100629, 87527, 84820, 100786, 86085, X1649, 504412, 504741, 87365, 102786, 104886, 103688, 86570, 102095, 103665, 100459, 103611, 102353, 104102, 100462, 103101, 103540, 85158, 103450, 102671, 102896, 102698, 83080, 103782.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales & Service Region No. America, Bothell, WA.
REASON Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Circle CÆ Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm,
Sterile. The product is a clear rigid plastic surgical tray containing components required for implantation.
Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an
outer clear plastic pouch. Catalog #DLC600-64C.

b) Circle CÆ Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm. The product is a clear rigid plastic surgical tray containing components required for implantation.
Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an
outer clear plastic pouch.
CODE
a) Lot Numbers 335418 and 356778;
b) Lot Numbers 3538781, 356779 & 342251.
RECALLING FIRM/MANUFACTURER Horizon Medical Products, Inc., Manchester, GA.
REASON The products have a potential defective seal that closes the productís OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
VOLUME OF PRODUCT IN COMMERCE 621 Units.
DISTRIBUTION Nationwide.

PRODUCT Computed Tomography, Models TSX-101A and TSZ-021A.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Toshiba American Med System, Inc., Tustin, CA.
REASON Erroneous patient data is entered. Previous patientís demographics are recorded.
VOLUME OF PRODUCT IN COMMERCE 552 units.
DISTRIBUTION Nationwide.

PRODUCT Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1.
CODE Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international).
RECALLING FIRM/MANUFACTURER American Medical Systems, Minnetonka, MN.
REASON Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.
VOLUME OF PRODUCT IN COMMERCE 62 kits.
DISTRIBUTION CT, IN, MI, NC, OH, TX, and Belgium.