JULY 2004

WEEK ENDING JULY 3

PRODUCT
a) Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
b) Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.
c) Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001.
CODE
a) Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724;
b) Serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.
c) Serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.
b) Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.
c) Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
CODE
a) All units (serial numbers 5583, 5606, 6372, 6394, 6396, 6398, 6558, 7210, 7574, 7595 and 7615);
b) All units (serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and
7724);
c) All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768).
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Tecan software has the potential to match the patient with a different patientís test result.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION Nationwide.

PRODUCT VerifyNow Asprin Assay Kit Part No. 85034.
CODE Assay Device Lot WD0034, Kit Lots W17105, W17140.
RECALLING FIRM/MANUFACTURER Accumetrics, Inc., San Diego, CA.
REASON Test results too low in control.
VOLUME OF PRODUCT IN COMMERCE 4,500 kits.
DISTRIBUTION Nationwide.

PRODUCT Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
CODE Ventilators with production serial numbers beginning with a "00" prefix.

IT IS MANOMETERS WITH PRODUCTION SERIAL NUMBERS BEGINNING WITH A ì00î PREFIX ‚ NOT VENTILATORS.
RECALLING FIRM/MANUFACTURER Sechrist Industries, Inc., Anaheim, CA.
REASON Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
VOLUME OF PRODUCT IN COMMERCE 240 ventilators or manometers.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Power Heart AED Automatic External Defibrillator, Model 9200 RD.
b) Power Heart Automatic External Defibrillator, Model 9210 RD.
CODE
a) Serial Numbers: 300122, 300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426, 306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through 308530, 308839, 309180, 309218, 309236, 309426, 309438, 309930, 309944, 309959, 309971 through 310170, 310181, 310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through 312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973, 317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278, 318171 - 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435, 318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043;
b) Serial Numbers: 300122,300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426,
306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through
308530, 308839, 309180, 309218, 309236, 309426, 309438, 309561, 309691 through 309894, 309897, 309903 through
309908, 309913, 309915, 309917, 309922, 309924, 309929, 309930, 309944, 309959, 309971 through 310170, 310181,
310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through
312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973,
317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278,
318171 - 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435,
318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043.
RECALLING FIRM/MANUFACTURER Cardiac Science, Inc., Minneapolis, MN.
REASON Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
VOLUME OF PRODUCT IN COMMERCE 6,167 defibrillators.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING JULY 10

PRODUCT
a) MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+.
b) MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted). CODE
a) Serial numbers 24371, 24372, 24374, 24375, 24376, 24377, 24379, 24380, 24495, 24496, 24497, 24498, 24499, 24500, 24501, 24502, 24503, 24504, 24505, 24506, 24507, 24508, 25560, 25561, 25562, 25564, 25566, 25567,
25568, 25569, 25570S, 25572, 25573, 25574, 25575, 25576, 25577, 25578, 25579, 25580, 25581, 25582, 25583, 25584S, 25585, 25586, 25587, 25588, 25589;
b) Model PM200R40: serial numbers 23528M, 23531M, 23533M, 23534M, 23535M, 23536M, 24360M, 24361M, 24363M, 24364M, 24365M, 24368M, 24369M, 25148M, 25149, 25390M, 25391M, 25392M, 25393M, 25394M, 25395M, 25396M, 25397M, 25400M, 25402M, 25403M, 25404M, 25405M, 25406M, 25407M, 25408, 26500M,
26501, 26502, 26503M, 26504M, 26505, 26506, 26508, 26509, 26510, 26511, 26512, 26513M, 26514, 26515, 26516, 26517, 26518, 26519 Model PW200R40, serial numbers 23530, 23538, 24362W, 24367W, 24369W, 25399W.
RECALLING FIRM/MANUFACTURER Minxray, Inc., Northbrook, IL.
REASON The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.
VOLUME OF PRODUCT IN COMMERCE 105 units.
DISTRIBUTION Nationwide.

PRODUCT Ant-Cer Dynamic Cervical Plating System Literature.
CODE All literature.
RECALLING FIRM/MANUFACTURER Spinal Concepts, Inc., Austin, TX.
REASON Recall of product literature that describes use of the device. Product literature implies that the plates ratchet mechanism is capable of preventing off-loading of the graft in extension. While the ratchet may offer some resistance in extension, it is neither intended to prevent off-loading of the graft nor disassociation of the plates. The two functions of the ratchet are to keep the plates in position during surgery and to allow the surgeon to set the desired amount of setting by the plate.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.

PRODUCT Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.
CODE Lot number 6234, EXP 10/20/04.
RECALLING FIRM/MANUFACTURER Digene Corp, Gaithersburg, MD.
REASON In vitro diagnostic test kit may produce false negative clinical results.
VOLUME OF PRODUCT IN COMMERCE 206 kits.
DISTRIBUTION Nationwide and the United Kingdom.

PRODUCT Synchromed II infusion pump.
CODE Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N.
RECALLING FIRM/MANUFACTURER Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN.
REASON The opposite version serial numbers are assigned to 20 mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician.
CODE Catalog Number: 001-1-110: Lot numbers.31005619, 040307981, 031105860, 040106663 Catalog Number: 001-1-320: Lot Numbers: 040308006, 040106665, 040307894, 031005622, 031105863, Catalog Number: 001-1-120: Lot Numbers: 040106664, 040307892, 040307982, Catalog Number: 001-1-140: Lot Number: 031065620 Catalog Number: 001-1-310: Lot Numbers: 031005621, 031105862, 040106667, 040307893, 040308005 Catalog Number: 001-1-330: Lot Numbers: 040106666, 040307895, 040308044.
RECALLING FIRM/MANUFACTURER Argon Medical Devices, Inc., Athens, TX.
REASON Inadequate closure compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 5,604 units.
DISTRIBUTION Nationwide and Japan.

PRODUCT Magnetic Resonance Imaging System(s) Visart and Exelart P2/Exelart P3/Exelart SPIN and Exelart VANTAGE.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc., Tustin, CA.
REASON Wrong positioning may cause patient burns.
VOLUME OF PRODUCT IN COMMERCE 58 units.
DISTRIBUTION Nationwide.

PRODUCT Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088.
CODE Lot: 1215.
RECALLING FIRM/MANUFACTURER The Straumann Co, Waltham, MA.
REASON Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN).
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION Nationwide.

PRODUCT AdvanceÆ Medical's, The Closed Camera System, 9" x 96" (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile. Recall # Z-1036-04.
CODE Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154.
RECALLING FIRM/MANUFACTURER Advance Medical Designs, Inc., Marietta, GA.
REASON The product may come apart when excessive force is applied to the coupler.
VOLUME OF PRODUCT IN COMMERCE 2340 units, *amended to include additional 250 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT Staar Surgical Intra Occular Lens, Collamer.
CODE All lenses packaged weeks of February 9-13 and 23-27.
RECALLING FIRM/MANUFACTURER Staar Surgical Co., Inc., Monrovia, CA.
REASON Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
VOLUME OF PRODUCT IN COMMERCE Not specified.
DISTRIBUTION Nationwide.

PRODUCT
a) Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles;
b) Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following sizes:
a.1) Ortho-Jet Powder, product code 1320, 100 g plastic squeeze bottle;
a.2) Biocryl Resin Acrylic, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle;
b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product CODE 1520, 100 g plastic squeeze bottle;
b.2) Contemporary Colored Assorted Kit, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit;
c.1) Electric Colored Ortho-Jet Powder, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit;
c.2) Tropical Tones Acrylic Resin, product code 045-052, 4 oz. plastic squeeze bottle.
c) Jet Denture Repair Acryulic, fast curing denture repair resin; PRODUCT code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package.
CODE
a) 2 oz. bottles: box lot 1410-4117, bottle lot 60074003/04AD - shade 62; box lot 1410-4120, bottle lot 60044001/01AE - shade 59; box lot 1410-4122, bottle lot 60123005/03AF - shade 69; 4 oz. bottles: box lot 1420-
4118, bottle lot 60083006/04AK - shade 65; box lot 1420-4119, bottle lot 60024001/01AJ - shade LI; box lot 1420-4120, bottle lot 60133003/03AJ ‚ shade 77; box lot 1420-4123, bottle lot 60143005/03AK - shade 81; box lot
1420-4126, bottle lot 60103002/02AD - shade 67; box lot 1420-4128, bottle lot 60024001/01AL - shade LI; box lot 1420-4130, bottle lot 60063002/02AU shade 61; box lot 1420-4131, bottle lot 60074003/04AE - shade 62; box
lot 1420-4134, bottle lot 60173001/01BU - shade C4; box lot 1420-4135, bottle lot 60084001/01AC - shade 65;
b) a.1) product code 1320, box lot 1320-4005, bottle lot 60274005/04AB;
a.2) product code 040-016, lot 53-1334-4016, empty bottle and cap only;
b.1) product code 1520, box lot 1520-4020, bottle lot 15144002/01AB ‚ Blue; box lot 1520-4023, bottle lot 15244006/01AH - White;
b.2) product code 045-088, box lot 53-1593-4006, bottle lots 15224001/01AQ - red, 15203002/01BS - orange, 15144002/01AA ‚ blue and 15124003/01AP - black, and box lot 53-1593-4007, bottle lots 15124003/01AQ - black, 15144002/01AC - blue, 15203002/01BU - orange, 15224001/01AT - red, 15244006/01AF - white, 15263001/01CD - yellow;
c.1) product code 2720, box lot lot 2720-4021, bottle lot 60374001/01AH ‚ pink; box lot 2720-4022, bottle lot 60363002/01BE -yellow; box lot 2720-4023, bottle lot 60374001/01AK - pink; product code 2793, kit box lot 2793-4005, bottle lots 60343002/02AF - green, 27124001/01AF - orange, 60374001/01AJ - pink, 27164001/01AS - red, 60363002/01BD ‚ yellow and 60353005/01AS - blue;
c.2) product 045-052, box lot 53-2720-4044, bottle lot 60343002/02AE ‚ key lime green;
c) Product code 1220, box lot 1220-4023, bottle lot 60274005/04AB - clear; product code 1223, box lot 1223-4024, bottle lot 60274005/04AB -clear and box lot 1223-4025, bottle lot 12163001/01AN - meharry.
RECALLING FIRM/MANUFACTURER Lang Dental Mfg., Co., Inc., Wheeling, IL.
REASON The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
VOLUME OF PRODUCT IN COMMERCE 474 units.
DISTRIBUTION Nationwide.

WEEK ENDING JULY 17

PRODUCT Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Model numbers CDB8003-01-US and CDB8053-01-US (with scale).

CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Arjo, Inc., Roselle, IL.
REASON There has been an increased number of tipping incidents and subsequent patient injuries.
VOLUME OF PRODUCT IN COMMERCE 1,032 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT TAXUSô Express2ô Paclitaxel-Eluting Coronary Stent System.
CODE 6294706 (Exp date June 2004), 6365192 (Exp date July 2004).
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Natick, MA.
REASON The problem consists of affected delivery catheters having resulted in slow or no balloon deflation during coronary angioplasty procedures.
VOLUME OF PRODUCT IN COMMERCE 200 devices.
DISTRIBUTION Nationwide and Canada.

PRODUCT Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
CODE Serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935.
RECALLING FIRM/MANUFACTURER Carl Zeiss Ophthalmic Systems, Inc, Dublin, CA.
REASON The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT VIDASÒ CMV IgG Assay, Catalog #30 204.
CODE Lot #782887501.
RECALLING FIRM/MANUFACTURER BioMerieux, Durham, NC.
REASON The product may give false positive results.
VOLUME OF PRODUCT IN COMMERCE 148 units.
DISTRIBUTION Nationwide.

PRODUCT ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit).
CODE List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200. List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON False positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
VOLUME OF PRODUCT IN COMMERCE 75,368 kits.
DISTRIBUTION Internationally.

PRODUCT Model 509M Pulse Oximetry Interface Module Software.
CODE Software versions 2.0 or 2.5.
RECALLING FIRM/MANUFACTURER Respironics Novametrix, Inc., Wallingford, CT.
REASON Audio alarm may fail to sound when Sp02 limits drop below the set limits.
VOLUME OF PRODUCT IN COMMERCE 901 units.
DISTRIBUTION Nationwide.

PRODUCT Clintec Micromix Compounder, an I.V. solution compounder; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted.
VOLUME OF PRODUCT IN COMMERCE 500 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers. CODE Multiple lot codes of Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers and multiple varieties and Lot Numbers of Flex Trays incorporating the clip appliers are subject to recall. The recalled codes represent all ER320 LIGACLIPS and/or kits containing ER320 LIGACLIPS, manufactured by the firmís plant in Juarez, Mexico from 12/10/2003 thru 2/5/2004. Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers - Lot Codes: U4YV53 U4YV54 U4YV54 U4YV54 U4YX01 U4YX07 U4YX07 U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX7Y U4YX7Y U4YX7Y U4YX84 U4YY5R U4YY5R U4YY5T U4YY5T U4YY5T V4YZ0C V4YZ0C V4YZ82 V4YZ82 V4YZ84 V4YZ8H V4YZ8H V4Z02U V4Z106 V4Z106 V4Z106 V4Z111 V4Z111 V4Z111 V4Z14R V4Z14R V4Z14R V4Z14R V4Z14W V4Z15U V4Z15U V4Z215 V4Z215 V4Z21F V4Z333 V4Z333 V4Z335 V4Z335 V4Z388 V4Z388 V4Z52V V4Z52V V4Z52Z V4Z57M V4Z62M V4Z62M V4Z66A V4Z66A V4Z66C V4Z66C V4Z724 V4Z724 V4Z837 V4Z838 V4Z882 V4Z882 V4Z883 V4Z883 V4Z95F V4Z95F V4Z964 V4Z964 V4Z964 V4Z99R V4Z99R V4Z99W V4Z99W V4Z99W V4ZA0X V4ZA0X V4ZA3V V4ZA3V V4ZA53 V4ZA53 V4ZA53 V4ZC1D V4ZC1D V4ZC1U V4ZC1U V4ZD02 V4ZD06 V4ZD06 V4ZD3X V4ZD3X V4ZD3X V4ZD52 V4ZD52 V4ZD52 V4ZD9E V4ZD9E V4ZE0H V4ZE0H V4ZE0H V4ZE61 V4ZE61 V4ZE7L V4ZE7L Flex Tray Gastric Trays - Kit Code: Lot Numbers: CBG17 V4Z63R CK017 U4YU9L CK017 U4YV4G CK017 U4YX3J CK017 U4YX5A CK017 U4YX5A CK017 U4YX5A CK017 U4YY23 CK017 V4YY8D CK017 V4YZ47 CK017 V4YZ47 CK017 V4Z00L CK017 V4Z24X CK017 V4Z36Y CK017 V4Z36Y CK017 V4Z45G CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z60U CK017 V4Z77E CK017 V4Z88G CK017 V4Z932 CK017 V4ZA59 CK017 V4ZA9R Flex Tray Bariatric Trays - Kit Code: Lot Numbers: FBW48 U4YX04 FBW48 V4Z344 FBW48 V4Z65G FBW48 V4ZD1C FBW64 V4Z829 FBW64 V4Z829 FBW64 V4ZE7K FBW79 U4YV5T FBW79 V4YZ53 FBW79 V4YZ53 FBW79 V4Z47T FBW79 V4Z62K FBW79 V4ZD1D FBW83 V4Z771 FBW83 V4Z771 FBW87 V4Z50Z KBW21 V4Z66D KBW21 V4ZC9T KBW21 V4ZC9T KBW29 V4Z797 KBW31 V4ZD48 KBW33 U4YV26 KBW33 U4YV26 KBW33 V4ZA3R KBW33 V4ZD1Y KBW47 V4Z16C KDW07 V4Z59L KDW07 V4Z59L KDW13 V4YZ3G KDW13 V4Z20W Flex Tray Access Trays - Kit Code: Lot Numbers: FDA47 U4YV2K FDA47 V4Z209 FDA47 V4Z789 FDA47 V4ZA4G FDA47 V4ZA4G Flex Tray Cholecsystectomy Trays: Kit Code: Lot Numbers: FDC10 U4YU37 FDC10 U4YX1K FDC10 U4YY1L FDC10 V4Z26M FDC10 V4Z29H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z514 FDC10 V4Z65C FDC10 V4Z65C FDC10 V4Z86F FDC10 V4Z86F FDC10 V4Z93N FDC10 V4ZA8D FDC10 V4ZD6U FDC10 V4ZE0N FDC10 V4ZF23 FDC11 U4YX9N FDC11 V4Z910 FDC12 U4YV02 FDC12 U4YV02 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 V4Z23A FDC12 V4Z945 FDC12 V4Z945 FDC12 V4ZA8M FDC12 V4ZA8M FDC13 U4YV03 FDC13 U4YV03 FDC13 V4Z137 FDC13 V4Z208 FDC13 V4Z208 FDC13 V4Z78C FDC13 V4ZC9Z FDC14 U4YU9X FDC14 V4Z83R FDC14 V4Z83R FDC15 U4YX27 FDC15 U4YX27 FDC15 V4Z22K FDC15 V4Z29E FDC15 V4Z37V FDC15 V4Z37V FDC15 V4Z93R FDC15 V4Z93R FDC15 V4Z957 FDC15 V4ZA62 FDC15 V4ZE0R FDC15 V4ZE0R FDC16 U4YU6G FDC16 U4YY4X FDC16 V4Z37A FDC16 V4Z49K FDC16 V4Z68K FDC16 V4Z68K FDC21 U4YW2T FDC21 V4Z93L FDC21 V4Z93L FDC22 U4YY52 FDC22 V4Z827 FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC32 U4YU3D FDC32 U4YX1L FDC32 U4YY6R FDC32 U4YY6R FDC32 V4Z59E FDC32 V4Z68H FDC32 V4Z68H FDC32 V4Z83U FDC32 V4Z83U FDC32 V4Z958 FDC32 V4Z958 FDC32 V4ZD55 FDC32 V4ZD57 FDC42 V4Z091 FDC42 V4Z95W FDC42 V4Z95W FDC42 V4Z95W FDC42 V4ZD5T FDC44 V4YY73 FDC46 V4Z150 FDC46 V4Z963 FDC46 V4Z963 FDC50 U4YV1Z FDC50 V4Z08G FDC50 V4ZE3D FDC56 V4Z83N FDC58 V4Z04A FDC58 V4Z04A FDC58 V4Z244 FDC58 V4Z86J FDC70 U4YX2A FDC70 V4Z896 FDC70 V4Z896 FDC70 V4ZD9U FDC70 V4ZF6F FDC79 U4YW3N FDC79 V4Z59H FDC79 V4Z59H FDC79 V4Z71X FDC79 V4Z71X FDC79 V4Z71X FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC81 U4YY0G FDC81 U4YY58 FDC81 U4YY58 FDC81 V4Z984 FDC81 V4Z984 FDC81 V4ZD5R FNC10 U4YW33 FNC10 V4Z27Y FNC10 V4Z71F FNC13 U4YV77 FNC13 V4Z561 FNC14 V4ZE3J FNC23 U4YU2F FNC23 U4YY47 FNC23 U4YY47 FNC23 V4Z50Y FNC23 V4ZD14 FNC28 U4YY0J FNC28 U4YY0J FNC28 V4Z20P FNC28 V4Z44R FNC28 V4Z44R FNC28 V4Z78A FNC28 V4ZC3V FNC28 V4ZC3V FNC29 U4YU03 FNC29 V4Z153 FNC29 V4Z17R FNC29 V4Z17R FNC29 V4ZC12 FNC29 V4ZC12 FNC30 U4YU21 FNC30 V4YZ3L FNC30 V4YZ3L FNC30 V4ZC17 FNC40 U4YW7K FNC40 V4Z181 FNC40 V4Z88N FNC40 V4ZE7T FNC40 V4ZE7T FNC41 U4YV01 FNC41 U4YV01 FNC41 V4Z26L FNC41 V4Z26L FNC41 V4Z515 FNC41 V4Z563 FNC41 V4Z69M FNC41 V4Z69M FNC41 V4Z86E FNC41 V4Z86E FNC41 V4Z86E FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZC1F FNC41 V4ZC1F FNC42 U4YV3T FNC42 V4Z04D FNC42 V4ZD4A FNC43 U4YW3M FNC43 U4YW3M FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z612 FNC43 V4Z75G FNC43 V4ZE64 FNC62 V4Z26C FNC62 V4Z26C FNC62 V4Z71U FNC62 V4ZC5L FNC69 V4Z37W FNC69 V4ZC1P FNC72 U4YU9Z FNC72 V4Z56J FNC73 U4YY4D FNC73 U4YY4D FNC90 U4YT8L FNC90 V4YZ3R FNC90 V4YZ8W FNC90 V4YZ8W FNC90 V4Z89J FNC90 V4Z89J FNC90 V4ZC3W FNC92 U4YV5A FNC92 U4YV5A FNC92 V4Z891 FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4Z88M FNC94 V4Z88M FNC94 V4ZC3T FNC94 V4ZC3T FNC94 V4ZC3T FNC99 V4Z63M FTC10 V4Z15D FTC10 V4Z94A FTC11 U4YU01 FTC11 V4Z94C FTC15 U4YX03 FTC15 U4YX03 FTC15 V4YZ2A FTR12 U4YU06 FTR12 V4YZ7N FTR12 V4YZ7N FTR12 V4ZE26 FTR12 V4ZE26 FTR13 V4ZD1T FTR32 U4YU05 FTR32 U4YY06 FTR32 V4YY8M FTR32 V4YY8M FTR32 V4YY8M FTR72 U4YY4F FTR72 U4YY4F FTR72 V4Z12A FTR72 V4ZD49 FTR72 V4ZD49 FTR73 V4Z88P KBC01 U4YW7C KBC01 V4ZD9D KBC06 V4Z79A KBC06 V4ZG3Y KBC07 U4YW94 KBC07 U4YW94 KBC07 V4Z29D KBC07 V4Z67H KBC07 V4Z758 KBC11 V4Z30H KBC23 V4Z635 KDC01 U4YX23 KDC03 V4Z14P KDC06 V4YZ7J KDC25 V4Z23N KDC26 U4YV3V KDC26 V4YZ2H KDC26 V4YZ2H KDC26 V4Z20H KDC26 V4Z897 KDC27 V4YZ2M KDC27 V4Z914 KDC32 V4Z13P KDC32 V4Z898 KDC32 V4ZC6M KDC32 V4ZC6M KDC33 V4Z796 KDC33 V4ZD01 KDC35 U4YU9Y KDC39 U4YV5V KDC39 V4Z17M KDC39 V4Z81U KDC40 U4YV1R KDC40 U4YV1R KDC40 U4YV1R KDC40 V4Z08E KDC51 V4Z47R KDC53 V4Z227 KDC61 U4YV75 KDC61 V4YZ7H KDC61 V4Z23E KDC61 V4Z68M KDC61 V4ZC84 KDC68 U4YW76 KDC68 U4YY07 KDC68 U4YY1A KDC68 U4YY1A KDC68 V4ZE68 KDC84 U4YW32 KDC84 V4Z56H KDC84 V4Z83M KDC84 V4Z83M KDC84 V4ZD71 KDC94 V4Z73N KNC03 U4YW3H KNC03 V4Z243 KNC03 V4Z243 KNC03 V4ZE7V KNC03 V4ZE7V KNC04 V4Z072 KNC04 V4Z072 KNC04 V4Z610 KNC07 U4YU6A KNC07 V4Z047 KNC07 V4Z047 KNC07 V4Z351 KNC07 V4Z65K KNC07 V4Z65K KNC07 V4ZD66 KNC08 U4YV1T KNC09 V4Z56G KNC09 V4Z56G KNC09 V4Z62J KNC09 V4ZE57 KNC19 U4YV9C KNC19 V4Z119 KNC19 V4Z772 KNC19 V4ZD5N KNC35 U4YX06 KNC35 U4YX06 KNC35 V4Z26K KNC35 V4ZD5L KNC35 V4ZD5L KNC60 U4YT6N KNC60 V4Z63K KNC60 V4Z63K KNC60 V4Z83P KNC74 U4YV9D KNC74 U4YV9D KNC74 V4Z26D KNC74 V4Z62N KNC76 V4YZ5P TDC04 V4Z04N TDC07 V4Z71Z TDC07 V4Z71Z TDC07 V4Z71Z TDC09 V4Z29F TDC27 U4YT89 TDC27 V4Z427 TDC27 V4Z427 TDC27 V4ZD16 TDC34 U4YU04 TDC34 V4Z44H TDC34 V4Z44H TDC37 V4Z238 TDC37 V4Z238 TDC37 V4ZD5K TDC39 V4YZ3P TDC39 V4YZ3P TDC41 V4Z26A TDC45 V4Z27N TDC49 V4Z324 TDC51 V4Z326 TDC51 V4Z326 TDC52 U4YU69 TDC54 U4YX3C TDC54 U4YX3C TDC54 V4Z34Y TDC54 V4ZD4D TDC59 V4Z346 TDC59 V4Z346 TDC59 V4ZA48 TDC61 U4YV2D TDC64 U4YV9W TDC64 U4YV9W TDC72 U4YW2J TDC72 V4ZD6C TNC07 U4YV60 TNC07 V4Z22J TNC12 U4YU29 TNC12 V4Z50R TNC12 V4Z50R TNC18 U4YT88 TNC18 V4Z42X TNC18 V4ZF1P TNC18 V4ZF1P TNC20 U4YT8E TNC20 U4YX05 TNC20 U4YX05 TNC20 V4Z350 TNC20 V4Z350 TNC20 V4Z68L TNC23 V4Z12K TNC23 V4Z12K TNC23 V4Z13M TNC23 V4ZE3E TNC23 V4ZE3E TNC24 U4YV3Z TNC24 V4YY8V TNC24 V4YY8V TNC29 V4ZD17 TNC36 V4Z560 TNC36 V4ZE28 TNC36 V4ZE28 TNC36 V4ZE28 TNC45 V4YZ6P TNC45 V4YZ6P TNC49 V4Z239 TNC49 V4Z239 TNC49 V4Z56K TNC49 V4ZD15 TNC56 V4Z83K TNC61 U4YV76 TNC61 V4Z21X TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4Z62Y TNC63 V4ZD9C TNC71 U4YW8M TNC71 V4Z09F TNC71 V4Z37C TNC80 V4Z37G TNC80 V4Z54F TNC80 V4ZD13 TNC81 V4Z34Z TNC85 V4Z65J TNC85 V4Z65J TNC87 V4Z12D TNC87 V4ZC6Y TNC88 V4Z95T TNC90 V4YZ6N TNC90 V4YZ6N TNC90 V4Z60V TNC90 V4ZC85 TNG92 U4YW31 TNG92 V4Z12C TNG92 V4Z68F VDC10 U4YW3G VDC10 U4YY4E VDC10 V4Z599 VDC10 V4Z65F VDC10 V4Z949 VDC15 U4YW72 VDC15 U4YW72 VDC15 V4Z513 VDC15 V4Z71R VDC15 V4Z71R VDC32 U4YV00 VDC32 U4YY1M VDC32 U4YY1M VDC32 V4Z83T VNC41 U4YV3U VNC41 V4Z30L VNC41 V4Z30L VNC41 V4Z614 VNC41 V4Z75L VNC42 V4Z04C VNC42 V4Z356 VNC42 V4Z356 VNC42 V4ZC1R VNC43 U4YV41 VNC43 U4YV41 VNC43 V4Z569 VNC43 V4Z569 VNC43 V4Z965 VNC94 V4Z14Z Flex Tray General Laparoscopy Trays - Kit Code: Lot Numbers: TGL21 U4YU02 TGL21 V4Z049 TGL21 V4Z049 TGL21 V4Z54D TGL32 V4Z029 TGL32 V4Z163 TGL44 V4Z449 TGL52 V4Z90Y.
RECALLING FIRM/MANUFACTURER Ethicon Endo-Surgery, Cincinnati, OH.
REASON This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.
VOLUME OF PRODUCT IN COMMERCE 1,204,015.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) CryoValve Pulmonary Valve SG.
b) CryoValve Pulmonary Valve and Conduit.
c) CryoValve Aortic Valve and Conduit.
CODE
a) Device Donor number: 64212, Serial Number: 7887101. Model Number: SGPV10;
b) Donor Number: 64208, Serial Number: 7887057, Model Number: SGPV00, Donor Number: 64222, Serial Number:
7894333, Model Number: SGPV00 and Donor Number: 64224, Serial Number: 7894298, Model Number: SGPV00;
c) Donor number: 64233, Serial Number: 7869358, Model Number: SGAV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA, OH, OR, and PA.

PRODUCT
a) ACCU-CHEK Inform meter; catalog No. 3035123.
b) ACCU-CHEK Inform base unit; catalog No. 3035131.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
VOLUME OF PRODUCT IN COMMERCE 41,544 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.
b) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.
CODE a) and b) Lot 14608300.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Device may report falsely decreased patient results.
VOLUME OF PRODUCT IN COMMERCE 312 kits.
DISTRIBUTION Nationwide, Canada, Germany and Spain.

PRODUCT Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIôE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603.
CODE All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected.
RECALLING FIRM/MANUFACTURER Osmetech, Inc., Roswell, GA.
REASON Patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as ìLowî.
VOLUME OF PRODUCT IN COMMERCE 1,012 boxes/25 cassettes per box.
DISTRIBUTION Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

PRODUCT Passport 2/Passport 2LT Vital Signs Monitor. Multi-parameter patient monitoring system.
CODE Serial Numbers: CM16830-E2; CM17664-C3; CM02100-D0; CM21267-B3; CM01262-B0; CM17728-F3; CM14167-L1; CM15062-B2; TM05314-D3; TM03604-A3; TM03630-A3; TM03642-A3; TM04059-B3; CM11122-F1; CM02057-D0; CM10756-F1; CM01376-B0; CM06107-K0; CM08770-C1; CM04116-H0; CM03838-G0; CM15058-B2; CM10359-F1; TM04721-C3; CM03958-G0; CM12388-I1; CM11462-G1; TM04175-B3; CM04386-H0; CM04445-H0; CM12571-I1; CM12778-I1; CM11479-G1; CM11776-H1; CM03556-F0; CM17319-E2; TM03982-A3; CM10360-F1; CM13887-K1; TM06058-F3; CM07526-B1; CM17683-F3; CM17715-F3; CM14479-A2; CM04265-H0; CM04703-I0; CM16756-E2; TM04809-C3; TM01569-H2; TM03602-A3; TM03603-A3; TM04091-B3; CM14979-B2; CM14986-B2; CM09445-D1; CM09479-D1; CM09935-E1; CM10117-E1; CM16268-D2; CM16451-D2; CM16540-D2; CM20116-F2; CM20117-F2; CM20130-F2; CM20160-F2; CM20196-F2; CM20203-F2; CM20216-F2; CM20218-F2; CM20219-F2; CM20220-F2; CM20221-F2; CM20529-F2; CM20531-F2; CM20533-F2; CM20537-F2; CM20538-F2; TM03635-A3; TM03639-A3; TM03647-A3; TM05447-E3; TM05457-E3; TM06085-G3; TM06109-G3; TM06119-G3; TM06129-G3; TM06152-G3; TM06154-G3; TM06170-G3; TM06270-H3; TM06280-H3; TM06282-H3; TM06317-H3; TM06337-H3; TM06363-H3; TM06386-H3; CM12173-H1; CM03670-F0; CM10041-E1; CM10721-F1; CM17422-E2; CM14065-L1; CM01200-L9; CM10711-F1; CM13006-J1; CM09686-D1; CM16023-C2; CM07488-B1; CM06584-L0; CM14498-A2; CM11945-H1; CM09924-E1; CM10163-E1; TM0555733-E3; CM12712-I1; TM04453-B3; TM03615-A3; CM04707-I0; CM08494-C1; TM04593-B3; TM06051-F3; CM04641-I0; CM12252-H1; CM16585-D2; CM04089-H0; CM09094-D1; TM06056-F3; TM06057-F3; TM06060-F3; YM06061-F3; CM06521-L0; CM04176-H0; TM01305-H2; TM03623-A3; TM03637-A3; TM03631-A3; CM04739-I0; CM13335-J1; CM05366-J0; CM05379-J0; CM07674-B1; CM12608-I1; CM04078-H0; TM01934-I2; TM03605-A3; TM03614-A3; CM05787-K0; CM12519-I1; CM16699-E2; CM09685-D1; CM10622-F1; CM13227-J1; CM17680-E3; TM02741-K2; CM05243-J0; CM05992-K0; CM13985-L1; TM05504-E3; TM03338-L2; CM11689-H1; TM04360-B3; CM03934-G0; CM10757-F1; CM10768-F1; CM10771-F1; TM05692-E3; TM05710-E3; CM1099-L9; CM17684-F3; CM16059-C2; CM03133-E0; CM01660-C0; CM15956-C2; CM14371-LI; CM06098-K0; CM07733-B1; CM09173-D1; CM06805-L0; CM10013-E1; CM04005-G0; CM07697-B1; TM05835-F3; TM05840-F3; TM05854-F3; TM05872-F3; TM05905-F3; TM05912-F3; TM05921-F3; TM05947-F3; TM05956-F3; CM01797-C0; TM02210-J2; CM05139-J0; CM11127-F1; TM01614-H2; CM09611-D1; TM05714-E3; TM03476-A3; TM03627-A3; TM03684-A3; TM05824-E3; CM07628-B1.
RECALLING FIRM/MANUFACTURER Datascope Corp., Mahwah, NJ.
REASON Potential inaccurate printed information in the upper and lower margins of a print strip.
VOLUME OF PRODUCT IN COMMERCE 244 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed).
CODE Serial numbers 166837 through 168088.
RECALLING FIRM/MANUFACTURER Bayer Healthcare LLC, Elkhart, IN.
REASON Some units may only have had 1 read head screw installed instead of the three required by the firmís specifications.
VOLUME OF PRODUCT IN COMMERCE 424 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device.
CODE Various serial numbers.
RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc., Tustin, CA.
REASON Pinhole collimator defective.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION Nationwide.

PRODUCT
a) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter.
Model #CAR-124, 6 units per case.
b) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter.
Model #CAR-153 Cartridge Express. 6 units per case.
c) NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #
CAR-154 Cartridge Express, 6 units per case.
CODE
a) Lot Numbers from and including FG-031216-01 to FG-040322-01;
b) Lot Numbers from and including FG-031216-01 to FG-040322-01;
c) Lot Numbers from and including FG-031216-01 to FG-040322-01.
RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA.
REASON Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate.
VOLUME OF PRODUCT IN COMMERCE 1,188 units.
DISTRIBUTION CA, IL, IN, MD, IA, MO, NJ, OH, and VT.

PRODUCT Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001.
CODE Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B.
RECALLING FIRM/MANUFACTURER Gen Probe, Inc., San Diego, CA.
REASON Reduced stability.
VOLUME OF PRODUCT IN COMMERCE 4,533 units.
DISTRIBUTION Nationwide.

WEEK ENDING JULY 24

PRODUCT TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm); and
TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
CODE MONORAIL Lot number: 6365192 (Exp date July 2004); Over-the-wire Lot number: 6294706 (Exp date June 2004).
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN.
REASON On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
VOLUME OF PRODUCT IN COMMERCE 208 Stent Systems.
DISTRIBUTION Nationwide and Canada.

PRODUCT Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells.
CODE Lot 1110 and Lot 2510 with exp. date of 8/11/04. EXPANDED 6/30/04 to include Lot 1130 and Lot 2530 with exp. date of 9/8/2004.
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY.
REASON Random occurrence of false positive test results.
VOLUME OF PRODUCT IN COMMERCE 5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04).
DISTRIBUTION Nationwide and Internationally.

PRODUCT Stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D.
CODE Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026.
RECALLING FIRM/MANUFACTURER Orbus Medical Technologies Inc, Fort Lauderdale, FL.
REASON Balloons have longer than expected deflation times.
VOLUME OF PRODUCT IN COMMERCE 22.
DISTRIBUTION CA.

PRODUCT Dispersive Electrodes packaged in an 8x10 plastic container.
CODE Lot codes affected: Y110503-1 and Y103003-2.
RECALLING FIRM/MANUFACTURER Rita Medical Systems, Mountain View, CA.
REASON Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
VOLUME OF PRODUCT IN COMMERCE 468 sets (each set consists of two pads).
DISTRIBUTION Nationwide.

PRODUCT GemStar® I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271.

CODE 95-156-5H, 05-027-5H, 09-208-5H.
RECALLING FIRM/MANUFACTURER Abbott Labs, Morgan Hill, CA.
REASON The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25°C (77° F).
VOLUME OF PRODUCT IN COMMERCE 18,432 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x ý” Reference Number: 4313..
CODE Lot Number: K527299.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Keene, NH.
REASON Sterility of product is not assured.
VOLUME OF PRODUCT IN COMMERCE 180 CASES (400/CS).
DISTRIBUTION Nationwide.

PRODUCT Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.
CODE Lot 412410 printed on carton.
RECALLING FIRM/MANUFACTURER Dynex Technologies, Inc., Chantilly, VA.
REASON An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.
VOLUME OF PRODUCT IN COMMERCE 1749 cartons.
DISTRIBUTION Nationwide and Internationally.

PRODUCT VSP Shock Module (as part of a prosthetic foot).
CODE RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
RECALLING FIRM/MANUFACTURER Ossur North America Inc, Aliso Viejo, CA.
REASON Flawed shock module might cause breakage causing patient to fall.
VOLUME OF PRODUCT IN COMMERCE 37 units.
DISTRIBUTION Nationwide.

PRODUCT Linear accelerator workstation software suite.
CODE MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Inc., Palo Alto, CA.
REASON An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
VOLUME OF PRODUCT IN COMMERCE 155 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths
packaged in 5 individual boxed kits per case carton.
b) SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These
sheaths are packaged in 5 individual boxed kits per case carton.
c) SafeSheath CSG (Coronary Sheath Guide) Multisite (MSP)-00-6.5 and CSG (Coronary Sheath Guide)
Multisite-00.09.
d) SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long. Recall # Z-1088-04.
CODE All lot numbers.
RECALLING FIRM/MANUFACTURER Thomas Medical Products Inc, Malvern, PA.
REASON Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
VOLUME OF PRODUCT IN COMMERCE 39,605 kits.
DISTRIBUTION CA and PA.

PRODUCT The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
CODE Lot numbers S000121, S000122, 300748, 300783, 300784, 300792, and 300822.
RECALLING FIRM/MANUFACTURER Vascular Solutions, Inc., Minneapolis, MN.
REASON The marker band in guidewire lumen could move from the manufactured location during clinical use.
VOLUME OF PRODUCT IN COMMERCE 1010.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Hill-Rom brand TotalCare Bed System; Model P1900.
CODE All beds built during April and May of 2004.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON An incorrect warning label was placed on these beds. Warning should say, “do not use for life sustaining equipment.....”.
VOLUME OF PRODUCT IN COMMERCE 180 beds.
DISTRIBUTION Nationwide and Canada.

PRODUCT ReFORM/SilverHawk Peripheral Atherectomy Catheters, packaging currently unknown.
CODE Lot codes 04052414 and 04052608.
RECALLING FIRM/MANUFACTURER Fox Hollow Technologies, Redwood City, CA.
REASON Gram positive Rod organisms were detected in samples after lab analysis.
VOLUME OF PRODUCT IN COMMERCE 127 units.
DISTRIBUTION Nationwide.

PRODUCT Introcan Safety IV Catheter 22G x 1” PUR with Wings. Catalog Number 4253540 - Catalog Number 4253540
CODE Lot number 3G26258U02, Lot number 3G27258U02.
RECALLING FIRM/MANUFACTURER Braun B Medical Inc., Allentown, PA.
REASON Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
VOLUME OF PRODUCT IN COMMERCE 85 units.
DISTRIBUTION Nationwide.

PRODUCT SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
CODE 8XRJ.
RECALLING FIRM/MANUFACTURER Bausch & Lomb Surgical, Inc., Clearwater, FL.
REASON Lens may be labeled with incorrect diopter size.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Fischer SenoScan True View Digital Mammography System.
CODE Product number 94829G-1, 94830G-1, 94830G-2.
RECALLING FIRM/MANUFACTURER Fischer Imaging Corp, Denver, CO.
REASON Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION FL, NC, NY, OK, WI, and France.

PRODUCT Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163.
CODE All software associated with Image Navigator feature in Magic View.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR images.
VOLUME OF PRODUCT IN COMMERCE 70 units.
DISTRIBUTION Nationwide.

****CORRECTION****

PRODUCT
a) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in 10 x 10 box (10 cartridges per blister pack;
10 blister packs per box; catalog number 150.0157.
b) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; catalog number 300.0419.
c) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0042.
d) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat
T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; catalog number 3001061.
e) Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; catalog number 150.0272.
f) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420.
g) Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051.

CODE All lots.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 208 lots.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use only, model
M001481541; Catalog No. 48-154.
b) Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model
M001482501, REF/Catalog No. 48-250.

CODE
a) Lots 6015906, 6028660, 6048137 and 6048138;
b) Lot 6015888.
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Spencer, IN.
REASON Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
VOLUME OF PRODUCT IN COMMERCE 2,590.
DISTRIBUTION Nationwide and Netherlands.

PRODUCT TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue. a) catalog #TFS30; b) catalog #TFR60.
CODE a) Lot number 002419 and b) lot number 002441.
RECALLING FIRM/MANUFACTURER Lifecore Biomedical, Inc., Chaska, MMN.
REASON Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
VOLUME OF PRODUCT IN COMMERCE 255.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Emission Computed Tomography System.

CODE Model number 2163-3000A, 2163-3000B; 510K K011611.
RECALLING FIRM/MANUFACTURER Adac Labs, Milpitas, CA.
REASON Software problems may cause the detector head to drift unexpectedly.
VOLUME OF PRODUCT IN COMMERCE 483 units.
DISTRIBUTION Nationwide.

PRODUCT FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container.
CODE Lot 012823 Exp October 2003.
RECALLING FIRM/MANUFACTURER Diagnostica Stago, Inc., Parsippany, NJ.
REASON The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.
VOLUME OF PRODUCT IN COMMERCE 965.
DISTRIBUTION Nationwide.

PRODUCT STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container.
CODE Lot number 02019. Exp. 1/31/2004.
RECALLING FIRM/MANUFACTURER Diagnostica Stago, Inc., Parsippany, NY.
REASON Incorrect assay ranges on the assay value insert for Heparin Control 5.
VOLUME OF PRODUCT IN COMMERCE 523.
DISTRIBUTION Nationwide.

PRODUCT Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
CODE Lots 6030323, exp. 01-Nov-06; 6348004, exp. 01-Mar-07 and 6313957, exp 01-Mar-07.
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Spencer, IN, by letter on June 30, 2004. Firm initiated recall is complete.
REASON Mislabeled as to size; 10FR are labeled as 8FR.
VOLUME OF PRODUCT IN COMMERCE 32.
DISTRIBUTION MO.

Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack

Ortho-Clinical Diagnostics notified healthcare professionals of a recall of four lots of the VITROS Troponin I Reagent Pack, a laboratory test used by professionals to measure the quantity of cardiac troponin I in human blood to aid in the diagnosis of heart attack. The recall was initiated due to random occurrences of false positive test results which could lead to unnecessary medical procedures. Clinical laboratories were instructed by the firm to stop using the product, discard any remaining material and notify the health care provider who ordered the test.

Product:Boston Scientific Express^2TM (bare metal) coronary stent system

Use: The Express^2™ stent system consists of a stent (small metal tube) which is mounted on a balloon catheter. The stent is inserted into a blood vessel and advanced within the vessel to the narrowed section of the coronary artery. When the stent is correctly positioned, the balloon is inflated, causing the stent to expand. Expansion of the stent pushes the plaque aside, opening the narrowed section of the artery restoring normal blow flow to the heart. The balloon on the stent delivery catheter is then deflated and the delivery catheter is removed from the patient. The stent remains permanently implanted supporting the newly opened section of the vessel.

Recalling Firm: Boston Scientific Corporation
1 Scimed Place
Maple Grove, MN 55311-1565

Reason for Recall:Characteristics in the design of this stent system resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement.

Public Contact: Boston Scientific Corporation
Tel: 800-832-7822

District:Minneapolis

For additional information on this product recall, see the Boston Scientific press release.

WEEK ENDING JULY 31

PRODUCT Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit No 31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.
CODE Lot 03419.
RECALLING FIRM/MANUFACTURER Integra Life Sciences Corp, Exton, PA.
REASON The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.
VOLUME OF PRODUCT IN COMMERCE 6 kits.
DISTRIBUTION NY.

PRODUCT Synchron LX Clinical Systems, Operating Software.

CODE All versions.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Numeric results are erroneously accepted by the in-house information system without qualifying symbols ì<î Or ì>î. In addition, the in-house system may interpret the results incorrectly.
VOLUME OF PRODUCT IN COMMERCE 816.
DISTRIBUTION Nationwide.

PRODUCT LDL Cholestrerol Reagent (LDLD) Part No. 969706.
CODE Lot M210044.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
VOLUME OF PRODUCT IN COMMERCE 291.
DISTRIBUTION Nationwide.

PRODUCT Synchron Systems Hemoglobin Alc (HbAlc) Reagent. Part 650252.
CODE Product Lot Numbers: M206003, M209057.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
VOLUME OF PRODUCT IN COMMERCE Not supplied.
DISTRIBUTION Nationwide.

PRODUCT LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003.
CODE Non-continuous Serial Numbers between 1178083 and 305080962.
RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA.
REASON Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.
VOLUME OF PRODUCT IN COMMERCE 41,936 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT SIEMENS AXIOM Artis ‚ AUTOMAP FUNCTION.
CODE Model Numbers: AXIOM Artis FC 5904433 AXIOM Artis BC 5904649 AXIOM Artis MP 5904466 AXIOM Artis FA 5904441 AXIOM Artis BA 5904656 AXIOM Artis TA 7007755 AXIOM Artis FC: 10050; 10052; 10055; 10064; 10072; 10086; 10094; 10124; 10148; 10151; 10153; 10176; 10177; 10182; 10198; 10217; 10228; 10237; 10240; 10243; 10249; 10251; 10253; 10266; 10284; 10298; 10307; 10326; 10335; 10338; 10348; 10364; 10365; 10367; 10369 AXIOM Artis BC: 14007 AXIOM Artis MP: 20022; 20024; 20032; 20036; 20045; 20048; 20070; 20078; 20082; 20090; 20094; 20107; 20110; 20111; 20155; 20169; 20177; 20190; 20199; 20203; 20205.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Berwyn, PA.
REASON Error appears in the AUTOMAP function, Module 2, when PERISTEPPING or PERIVISION is activated simultaneously that causes system to crash.
VOLUME OF PRODUCT IN COMMERCE 127 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for
bradycardia (slow heart rhythm). Model 701 KVDD IPGs provide atrial sensing and do not provide
atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing;
also by design.
b) Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies
for bradycardia (slow heart rhythm). Model 901 KVDD IPGs provide atrial sensing and do not provide
atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing;
also by design.
CODE
a) Serial numbers:PHP639142S, PHP639071S, PHP641397S, PHP641427S, PHP639084S, PHP637588S, PHP641973S,
PHP638150S, and PHP640598S;
b) Serial numbers:PLE100772H, PLE100708H, PLE100832H, PLE721316S, PLE721730S, PLE722475S, PLE722599S,
PLE722786S, PLE721384S, PLE722723S, PLE723479S, PLE723562S, PLE722865S, PLE722865S, PLE723451S,
PLE721760S, PLE721309S, PLE723579S, PLE723754S, PLE722993S, and PLE723183S.
RECALLING FIRM/MANUFACTURER Medtronic Inc., Cardiac Rhythm Management, Fridley, MN.

REASON Potential problems with the programmer interface. Kappa Model KVDD 701/901 IPG's that were processed through the Distribution Center Restock Tester (DCRT) have an inadvertent error of having the atrial amplitude programmed on and set to 3.5V. For the Kappa KVDD device, atrial amplitude programmed on is considered an invalid parameter by the programmer software, consequently the Model 9790 or 2090 Programmer will not allow a Real Time Telemetry (RTT) measurement to be performed upon initial device interrogation or via battery and lead impedance measurement screens. Therefore, battery measurements, estimated longevity, and lead impedance measurements are not available via RTT.
VOLUME OF PRODUCT IN COMMERCE 30 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Metricath Balloon Catheter model #RX183670.
CODE Not supplied.
RECALLING FIRM/MANUFACTURER Angiometrx Inc., Vancouver, Canada.
REASON Sterility of the device could have been compromised.
VOLUME OF PRODUCT IN COMMERCE 300.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Cell-Dyn 1000 series platelet analyzer (model numbers 1300, 1400, 1600, 1700, 1800).
CODE List numbers 91361-01,-03 (CD1300), 91360-03 (CD1300), 91336-01,-03 (CD 1400), 91377-01,-03 (CD 1400 CS), 91338-01, -03 (CD 1400 w/ RS232), 91339-01,-03 (CD 1400 CS w/ RS232) 91373-01, -03 (CD1600 CS 220v), 91375-01,-03 (CD 1600 CS 220v), 91374-01, -03 (CD 1600 CS120v), 91372-01,-03 (CD 1600 CS120v) 03H57-01, -03 (CD 1700 CS), 03H53-01, -03 (CD 1700), 07H77-01 (CD1800)-- 510k: 13/1400: K903665/A, 16/1700: K870233, 1800: K030513.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA.
REASON Analyzer may generate inaccurate PLT concentration counts which may result in overestimation of true PLT concentration.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Gertie Marx PainPak, Reorder number 4060.
b) Pencil Point Spinal Tray.
CODE
a) Lot # 0504305;
b) Lot # 0504243.
RECALLING FIRM/MANUFACTURER Spinal Specialties, Inc., San Antonio, TX.
REASON Kit contains lidocaine, which has particulate matter in its ampule.
VOLUME OF PRODUCT IN COMMERCE 80 units.
DISTRIBUTION TX and MI.

PRODUCT Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.
CODE All lots.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Sample values may be decreased by between 9 and 12 percent.
VOLUME OF PRODUCT IN COMMERCE Not supplied.
DISTRIBUTION Nationwide.

PRODUCT Synchron LX Clinical Systems Software.
CODE All Software versions.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON ìInitial Rate Highî parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
VOLUME OF PRODUCT IN COMMERCE Not supplied.
DISTRIBUTION Nationwide.

PRODUCT Aeroset Prealbumin Reagent, LN 1E02-01.
CODE Reagent Application sheet number 30-2442/R5/May 2000.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div, South Pasadena, CA.
REASON False Positive results possible.
VOLUME OF PRODUCT IN COMMERCE 161.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only.
b) Ventilator Circuit with ìYî & elbow with 2 Water Traps, for use with/compatible with Bennett 7200;
product reorder 6072WT; SIngle Patient Use only;
c) Disposable Water Trap with "T" for Ventilator Circuits; product reorder 6090; SIngle Patient

Use only; IPI label.
d) Disposable Water Trap with "Y" for Ventilator Circuits; product reorder 6091; SIngle Patient Use only;

e) Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84î Tube (3 in 1 mask); reorder no. 7020; Single Patient Only;
f) Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84" Tube; reorder no. 7022;
CODE
a) Lot L050;
b) Lots B16C002, M156, M261, N090, N160;
c) Lots H308, J083, J244, J245, J251, J351, J363, J364, K293, K297, L011, L169A;
d) Lots H197, J057, J147, J174, J216, J267, K070, K311, L171, L275, M225, M343, N065, N178, N233;
e) Lots K235, K277A, J135R, J142, M196, M337, N107;
f) Lot K307.
RECALLING FIRM/MANUFACTURER Medex Inc., Dublin, OH.
REASON The non-rebreathing masks and watertraps wee manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex.
VOLUME OF PRODUCT IN COMMERCE 11,000 units.
DISTRIBUTION Nationwide.

PRODUCT HA Hip Stem, cementless, Part number 470-02-090.
CODE Lot 938381.
RECALLING FIRM/MANUFACTURER Encore Medical, LP, Austin, TX.
REASON Hip stem product was mislabeled with wrong size.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.

PRODUCT
a) Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;
b) ThermovenT 600, Heat and Moisture Exchangers Catalog # 580011.
c) Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021.
CODE
a) Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160;
b) Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160;
c) Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160.
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Keene, NH.
REASON Sterility of the device is compromised due to lack of package integrity.
VOLUME OF PRODUCT IN COMMERCE 5,781 (50/case).
DISTRIBUTION Nationwide.

PRODUCT Encision ES4107 Disposable AEM Cord, Sterile. REF ES4107.
CODE Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE,HF HFA, HG, HI.
RECALLING FIRM/MANUFACTURER Encision, Inc., Boulder, CO.
REASON Firm found pinholes in packaging which would compromise sterility.
VOLUME OF PRODUCT IN COMMERCE 73 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT 18 G Catheter is a component in various kits..
CODE Catalog/Lot numbers, respectively: 331411/60463283; 331412/60463404; 331417/60440555; 331542/60437004; 331545/60460702; 331565/60468520; 331565/60481188; 331567/60451432; 331567/60481276; 331582/60433989; 331583/60437935; 331585/60454731; 331585/60477325; 331587/60440553; 331592/60454732; 331595/60460707; 331712/60460705; 331812/60444733; 331918/60454742; 331935/60430137; 58003/60447789 ; 580099/60452854; 580125/60480896; 58017660456867 ; 580179/60453991; 580187/60444305; 7B3013/60459863; 7B3040/60451968; S1200600N/60425597; S1200600N/60451313 S1200600N/60435666; S1200600N/60451450.
RECALLING FIRM/MANUFACTURER Braun, B Medical Inc, Allentown, PA.
REASON Catheter separated from the hub.
VOLUME OF PRODUCT IN COMMERCE 1,176 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) CryoValve, Aortic Valve, Model Number: AV00.
b) CryoValve, Conduit and Pulmonary Valve, Model Number: PV00.
CODE
a) Serial Number: 8178439;
b) Serial Number: 8178422.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and TX.

PRODUCT
a) Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol
prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits
per case: a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000; b)Medikmark Inc. Staple Removal
Set, reorder no. SR-2000; c) Maxxim Medical StapleRemoval Kit, reorder no. SD-2000.
b) MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple
remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case;
c) Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge.
These kits were marketed under the following labels,50 kits per case: a) Medikmark inc. Staple Removal Set,
reorder no. SR-2005; b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005.
CODE
a) Reorder no. RS-2000: lot 304075; reorder no. SR-2000: lots 201106, 205173, 209014, 210017, 211084, 301059,
303069, 305096, 305143, 308044, 310136, 311136, 312059, 401132, 404160, 405062, 406018; reorder no. SD-2000:
lot 204019;
b) Lots 305097, 306073, 306212, 312109, 401003, 101133, 403154, 404040, 405003, 406021;
c) Reorder no. SR-2005: lots 308045, 309064, 310137, 406019; reorder no. SD-2005: lots 201107, 203003, 204020, 205035, 205172, 207044, 207101, 208125, 210016, 211007, 301006, 302090, 304070, 305043, 306201, 307075, 308071, 309034, 310124, 312017, 401065, 404004.
RECALLING FIRM/MANUFACTURER Medikmark, Inc., Waukegan, IL.
REASON The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
VOLUME OF PRODUCT IN COMMERCE 93,500 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) Advent Implant Line.
b) Biovent Implant Line.
c) Microvent Implant Line.
d) Screwvent Implant Line.
e) Swedevent Implant Line.
f) Swissplus Implant Line.
g) Taperlock Implant Line.
CODE
a) Advent Implant Line Part # Description Lot Number Quantity AVACT Scr, Tapered Abut, AdVent 013789 299 AVACT Scr, Tapered Abut, AdVent 015135 166 AVACT Scr, Tapered Abut, AdVent 015548 499 AVACT Scr, Tapered Abut, AdVent 016679 229 AVACT Scr, Tapered Abut, AdVent 017539 300 AVACT Scr, Tapered Abut, AdVent 017539 100 AVACT Scr, Tapered Abut, AdVent 0202675 197 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 017540 50 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 0200281 70 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 0202676 69 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 013555 318 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 016159 401 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 0201977 295 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 014357 143 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 014869 149 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 015474 100 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 016160 389 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 017701 255 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 0202330 197 AVB16 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 16mm 016161 200 AVB16 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 16mm 0202621 86 AVB8 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 8mm 0200502 49 AVBA Abut, Ball, Advent, 1mm 012719 149 AVBA Abut, Ball, Advent, 1mm 013557 260 AVBA Abut, Ball, Advent, 1mm 015192 98 AVBA Abut, Ball, Advent, 1mm 015389 310 AVBA Abut, Ball, Advent, 1mm 016162 300 AVBA Abut, Ball, Advent, 1mm 016458 200 AVBA Abut, Ball, Advent, 1mm 016593 296 AVGA Abut, Gold, Friction-Fit, Advent 015472 100 AVGA Abut, Gold, Friction-Fit, Advent 016592 50 AVGA Abut, Gold, Friction-Fit, Advent 016916 150 AVGA Abut, Gold, Friction-Fit, Advent 0201251 47 AVGA Abut, Gold, Friction-Fit, Advent 0202678 68 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 013175 251 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 014836 174 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016064 161 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016566 245 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016815 80 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 017438 87 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 017702 261 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 0201825 85 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 0202331 87 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 013176 357 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 014259 86 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 015986 83 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016312 261 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016343 153 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016586 151 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017558 147 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017660 167 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017705 94 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0200271 89 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0200503 94 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0202196 153 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0202889 71 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 013790 160 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 015107 123 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 016587 88 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 016910 74 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 0200116 82 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 0202506 70 AVH20/4 Abut, 20 deg, AdVent Imp 012524 69 AVH20/4 Abut, 20 deg, AdVent Imp 014803 50 AVH20/4 Abut, 20 deg, AdVent Imp 015948 28 AVH20/4 Abut, 20 deg, AdVent Imp 017358 297 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 014358 50 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 015469 48 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 016163 209 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 016163 100 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 013320 66 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 013493 480 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 015497 321 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 016653 106 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 017686 150 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 017686 50 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0200504 199 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0201249 50 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0201724 198 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0202569 199 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 016344 51 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 017688 50 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 0200995 50 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 0201603 74 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 013177 300 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 015316 300 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 016746 96 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 -245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200996 95 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0202306 194 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0204454 70 AVPC Coping, Plastic Castable, Advent Imp 0200200 95 AVPC Coping, Plastic Castable, Advent Imp 0202543 50 AVR Replica, AdVent Implant 012358 270 AVR Replica, AdVent Implant 014243 400 AVSC Scr, Surgical Cover, Ti, Flat, AdVent Imp 014983 200 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 015090 223 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 017730 150 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 0200997 48 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 014609 49 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 015045 50 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 015045 235 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 016762 120 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 0200505 147 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 0201863 146 AVWB16 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 16mm 016184 100 AVWB8 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 8mm 0202663 100 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 012366 100 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 014359 49 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 014870 201 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017592 60 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017661 72 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017762 67 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0200632 76 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0200684 78 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0201944 56 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0202010 70 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0204366 87 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 012854 262 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 016267 27 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 016929 52 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 017009 59 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 017482 143 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0200123 50 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0201325 85 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0201663 183 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0202045 86 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 014419 47 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 016164 57 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 0200779 90 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 0202300 44 AVWH8 Imp, AV, HA, 4.7mm, 4.5mm Interface, 8mm 0201329 50 AVWH8 Imp, AV, HA, 4.7mm, 4.5mm Interface, 8mm 0202664 87;
b) BioVent Implant Line Part # Description Lot Number Quantity BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 014528 294 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017357 81 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017725 89 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 02000087 196 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 014684 112 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 016795 89 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 017488 90 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 0200201 93 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 013178 300 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 014531 382 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 017726 51 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200685 96 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200861 243 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 012359 87 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 013829 98 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 015111 99 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 016955 85 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 017703 50 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 0200088 94 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 012855 41 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 014484 80 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 017587 42 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 0201661 39 BVT13 IMPLANT,B-V,INT HEX,1MM CLR,TPS,13MM L 0201113 36 BVT13W Imp, Bio-Vent, TPS, 4.5mm, 13mm 0200249 50 BVT16 Imp, Bio-Vent, TPS, 3.5mm, 16mm 0200250 50 BVT16W Imp, Bio-Vent, TPS, 4.5mm, 16mm 0201145 100;
c) MicroVent Implant Line Part # Description Lot Number Quantity MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0200515 100 MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0202923 100 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 014962 270 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 0200428 200 MV3H8 Impl, M-V II, HA, 3.7mm, 8mm 0202162 30 MV4H10 Impl, M-V II, HA, 4.7mm, 10mm 0200516 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 016646 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 0200427 100 MV4H8 Impl, M-V II, HA, 4.7mm, 8mm 0201180 35;
d) ScrewVent Implant Line Part # Description Lot Number Quantity A5H20 Abut, 20 deg, 5.7mm Imp 015124 60 A5H20/6 Abut, 20 deg, 5.7mm Imp Hex-Lock 015269 99 A5H20/6 Abut, 20 deg, 5.7mm Imp Hex-Lock 0201248 64 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 013471 598 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 015416 295 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 016062 397 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 016511 389 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 017024 299 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 0200630 119 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 0202412 337 ACB2 Screw, Ball Abut, Scr-V, 2mm Collar, 3.5mm Imp 0202871 389 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 012930 330 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 015187 218 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 016030 300 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 016512 266 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 0200197 300 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 0201162 249 ACB4 Screw, Ball Abut, Scr-V, 4mm Collar, 3.5mm Imp 0201942 194 ACB6 Screw, Ball Abut, Scr-V, 6mm Collar, 3.5mm Imp 013081 99 ACB6 Screw, Ball Abut, Scr-V, 6mm Collar, 3.5mm Imp 015495 75 ACB6 Screw, Ball Abut, Scr-V, 6mm Collar, 3.5mm Imp 016638 69 ACB6 Screw, Ball Abut, Scr-V, 6mm Collar, 3.5mm Imp 0201656 59 ACBS2 Screw, Replacement, Scr-V, 2mm Ball Abut 013427 30 ACBS6 Screw, Replacement, Scr-V, 6mm Ball Abut 014812 50 ACBW2 Screw, Ball Abut, Scr-V, 2mm, 4.5mm Imp 013349 253 ACBW2 Screw, Ball Abut, Scr-V, 2mm, 4.5mm Imp 016639 100 ACBW2 Screw, Ball Abut, Scr-V, 2mm, 4.5mm Imp 0200198 100 ACBW2 Screw, Ball Abut, Scr-V, 2mm, 4.5mm Imp 0201254 53 ACBW2 Screw, Ball Abut, Scr-V, 2mm, 4.5mm Imp 0202057 60 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 013577 87 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 014239 78 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 016031 80 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 016712 100 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 0201163 50 ACBW4 Screw, Ball Abut, Scr-V, 4mm, 4.5mm Imp 0202058 68 ACBW6 Screw, Ball Abut, Scr-V, 6mm, 4.5mm Imp 013551 50 ACBW6 Screw, Ball Abut, Scr-V, 6mm, 4.5mm Imp 0201657 85 ACT3 Scr, Tapered Abut, Scr-V, 3mm, 3.5mm Imp 013350 440 ACT3 Scr, Tapered Abut, Scr-V, 3mm, 3.5mm Imp 017004 200 ACT3 Scr, Tapered Abut, Scr-V, 3mm, 3.5mm Imp 017535 129 ACT3 Scr, Tapered Abut, Scr-V, 3mm, 3.5mm Imp 0201859 180 ACT4 Scr, Tapered Abut, Scr-V, 4mm, 3.5mm Imp 014279 66 ACT4 Scr, Tapered Abut, Scr-V, 4mm, 3.5mm Imp 015220 50 ACT4 Scr, Tapered Abut, Scr-V, 4mm, 3.5mm Imp 017284 231 ACT4 Scr, Tapered Abut, Scr-V, 4mm, 3.5mm Imp 0200086 70 ACT4 Scr, Tapered Abut, Scr-V, 4mm, 3.5mm Imp 0200386 56 ACT6 Scr, Tapered Abut, Scr-V, 6mm, 3.5mm Imp 015291 49 ACTDT Transfer, Direct, Tapered Abut 012712 114 ACTDT Transfer, Direct, Tapered Abut 013552 183 ACTDT Transfer, Direct, Tapered Abut 014783 136 ACTDT Transfer, Direct, Tapered Abut 016884 474 ACTDT Transfer, Direct, Tapered Abut 017536 244 ACTDT Transfer, Direct, Tapered Abut 0202567 148 ACTGC Coping, Gold, Tapered Abut 012744 497 ACTGC Coping, Gold, Tapered Abut 013553 360 ACTGC Coping, Gold, Tapered Abut 014800 498 ACTGC Coping, Gold, Tapered Abut 016735 569 ACTGC Coping, Gold, Tapered Abut 017483 477 ACTGC Coping, Gold, Tapered Abut 0201164 300 ACTGC Coping, Gold, Tapered Abut 0201722 250 ACTIT Transfer, Indirect, Tapered Abut 013351 397 ACTIT Transfer, Indirect, Tapered Abut 015086 398 ACTP Coping, Plastic Castable, Tapered Abut 013355 594 ACTP Coping, Plastic Castable, Tapered Abut 014612 599 ACTP Coping, Plastic Castable, Tapered Abut 015244 698 ACTP Coping, Plastic Castable, Tapered Abut 016185 372 ACTP Coping, Plastic Castable, Tapered Abut 017119 600 ACTP Coping, Plastic Castable, Tapered Abut 017484 590 ACTP Coping, Plastic Castable, Tapered Abut 0201253 489 ACTR Replica, Tapered Abut 012708 600 ACTR Replica, Tapered Abut 013931 140 ACTR Replica, Tapered Abut 014481 500 ACTT Temporary, Ti, Tapered Abut 012691 80 ACTT Temporary, Ti, Tapered Abut 013472 77 ACTT Temporary, Ti, Tapered Abut 014482 260 ACTT Temporary, Ti, Tapered Abut 017356 299 ACTTC ABUT,TPRD,TI COPING 0200199 29 ACTW3 Scr, Tapered Abut, Scr-V, 3mm, 4.5mm Imp 015136 58 ACTW3 Scr, Tapered Abut, Scr-V, 3mm, 4.5mm Imp 015417 50 ACTW3 Scr, Tapered Abut, Scr-V, 3mm, 4.5mm Imp 017537 50 ACTW3 Scr, Tapered Abut, Scr-V, 3mm, 4.5mm Imp 0200279 49 ACTW4 Scr, Tapered Abut, Scr-V, 4mm, 4.5mm Imp 0200280 50 ACTW6 Scr, Tapered Abut, Scr-V, 6mm, 4.5mm Imp 013936 49 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 014388 494 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 015095 399 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 016157 391 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 016911 250 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 016911 249 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 0200387 208 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 0201515 250 AH20 Abut, 20 deg, Scr-V, Base, 3.5mm Imp 0202508 403 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 012652 597 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 013746 398 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 014758 102 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 015987 500 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 016032 394 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 017538 312 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 0200004 600 AH20/4 Abut, 20 deg, Scr-V, 3.5mm Imp 0200501 568 AH20S Scr, Replacement, Scr-V, 20 deg Abut, Int Hex 012929 100 AH20W Abut, 20 deg, Scr-V, Base, 4.5mm Imp 013469 298 AH20W Abut, 20 deg, Scr-V, Base, 4.5mm Imp 016158 147 AH20W Abut, 20 deg, Scr-V, Base, 4.5mm Imp 017120 249 AH20W Abut, 20 deg, Scr-V, Base, 4.5mm Imp 0200994 99 AH20W Abut, 20 deg, Scr-V, Base, 4.5mm Imp 0201516 119 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 013554 149 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 014405 179 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 016198 300 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 016678 270 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 0202329 250 AH20W/5 Abut, 20 deg, Scr-V, 4.5mm Imp 0202568 200 BAR Replica, Ball Abut, Two-Piece & CBA 012714 497 BAT Tranfers, Ball Abut, Two-Piece & CBA 012931 311 BAT Tranfers, Ball Abut, Two-Piece & CBA 015096 497 BTO Replica, Abut, Straight, TSI Series 014414 399 CA Housing, Cap Att, Nylon Liner, Ball Abut 013173 150 CA Housing, Cap Att, Nylon Liner, Ball Abut 015390 148 CA Housing, Cap Att, Nylon Liner, Ball Abut 016680 100 CAB Pattern, Castable Ball, Cap Att 016345 50 CAH Housing, Cap Att, Stainless Steel 013468 599 CAH Housing, Cap Att, Stainless Steel 015512 600 CAH Housing, Cap Att, Stainless Steel 016764 498 CAN Cap Attachment Nylon Liner 012703 598 CAN Cap Attachment Nylon Liner 012879 595 CAN Cap Attachment Nylon Liner 012880 699 CAN Cap Attachment Nylon Liner 013826 683 CAN Cap Attachment Nylon Liner 015189 800 CAN Cap Attachment Nylon Liner 015190 796 CAN Cap Attachment Nylon Liner 015318 800 CAN Cap Attachment Nylon Liner 015510 777 CAN-G Cap Attachment Nylon Liner, Rigid Retention 012850 252 CAN-G Cap Attachment Nylon Liner, Rigid Retention 014099 250 CAN-G Cap Attachment Nylon Liner, Rigid Retention 014759 400 CAN-G Cap Attachment Nylon Liner, Rigid Retention 015937 450 CANM Cap Attachment Nylon Micro 015241 75 CANM Cap Attachment Nylon Micro 015938 50 CANM Cap Attachment Nylon Micro 016957 50 CAT Transfer, Cap Attachment 012713 400 CAT Transfer, Cap Attachment 014958 158 CHLA/4 Adapter, Hex-Lock Abut, Complete Imp, 4.5mm 0200390 40 CHLAS SCREW,FIXATION,COMPLETE HEX-LOCK ABUTMENT 014392 49 DE Drill Extender 013946 150 DE Drill Extender 014982 199 DHT3/3 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 3.5mm Imp 013921 102 DHT3/3 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 3.5mm Imp 013921 80 DHT3/3 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 3.5mm Imp 017584 73 DHT3/3 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 3.5mm Imp 0200434 200 DHT3/3 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 3.5mm Imp 0201947 100 DHT3/4 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 4.5mm Imp 012924 504 DHT3/4 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 4.5mm Imp 015104 210 DHT3/4 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 4.5mm Imp 015965 400 DHT3/4 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 4.5mm Imp 017030 147 DHT3/4 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 4.5mm Imp 0201250 256 DHT3/5 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 5.5mm Imp 014861 150 DHT3/5 Xfr, Hex, Direct, Scr-V, 3.5mm Neck, 5.5mm Imp 0201725 99 DHT4/4 Xfr, Hex, Direct, Scr-V, 4.5mm Neck, 4.5mm Imp 014485 199 DHT4/4 Xfr, Hex, Direct, Scr-V, 4.5mm Neck, 4.5mm Imp 016714 150 DHT4/4 Xfr, Hex, Direct, Scr-V, 4.5mm Neck, 4.5mm Imp 0202571 100 DHT4/5 Xfr, Hex, Direct, Scr-V, 4.5mm Neck, 5.5mm Imp 015553 200 DHT4/5 Xfr, Hex, Direct, Scr-V, 4.5mm Neck, 5.5mm Imp 0201865 75 FMTM2 Mini Abut / Transfer 015720 100 GPS Coping, Gold, Straight Abut, TSI Series 016611 22 GPS1 Coping, Gold, Tapered Abut, TSI Series 016513 30 HACDT Transfer, Direct, Hexed Abut 0201179 30 HGC3 Coping, Gold, 3mm Bar, Hex Abut 013576 48 HLA2F Abut, Hex-Lock, 3.5mm Imp, 2mm Hex Thread 013424 50 HLA2F Abut, Hex-Lock, 3.5mm Imp, 2mm Hex Thread 015242 50 HLA2F Abut, Hex-Lock, 3.5mm Imp, 2mm Hex Thread 016715 50 HLA2F Abut, Hex-Lock, 3.5mm Imp, 2mm Hex Thread 0202546 50 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 013213 600 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 014486 452 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 015152 170 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 015612 699 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 016348 597 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 017247 507 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 0201001 200 HLA3/3 Abut, Hex-Lock, 3.5mm Imp, 3.5 Flare 0201605 510 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 012237 87 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 012238 100 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 012239 98 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 012721 599 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 013180 598 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 013403 700 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 013558 699 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 014091 800 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 014487 499 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015153 697 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015154 795 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015319 800 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015498 799 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015884 759 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 015966 794 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 016125 800 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 016460 735 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 017288 998 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 017489 936 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 0200204 720 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 0200888 998 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 0201167 1298 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 0201890 999 HLA3/4 Abut, Hex-Lock, 3.5mm Imp, 4.5 Flare 0202046 923 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 013933 700 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 015155 246 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 015499 600 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 016126 499 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 016748 394 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 017490 323 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 0201003 300 HLA3/5 Abut, Hex-Lock, 3.5mm Imp, 5.5 Flare 0201866 350 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 012050 595 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 012938 499 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 013179 506 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 014233 559 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 014829 179 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 015014 490 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 015151 399 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 015391 498 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 015885 355 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 016065 367 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 016736 991 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 016749 990 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 0200797 988 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 0200836 786 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 0201606 980 HLA3G Abut, Gold, Friction-Fit, 3.5mm Imp 0202547 795 HLA3T Abut, Ti, Friction-Fit, 3.5mm Imp 013214 290 HLA3T Abut, Ti, Friction-Fit, 3.5mm Imp 015091 400 HLA3T Abut, Ti, Friction-Fit, 3.5mm Imp 016716 286 HLA3T Abut, Ti, Friction-Fit, 3.5mm Imp 0201726 197 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 013082 600 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 013559 700 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 014488 472 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 015156 800 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 015554 714 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 016349 782 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 016958 600 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 0200205 499 HLA4/4 Abut, Hex-Lock, 4.5mm Imp, 4.5 Flare 0200467 509 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 012722 600 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 013560 700 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 014277 150 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 014277 450 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 015157 91 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 015157 609 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 015320 423 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 015320 250 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 016127 800 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 016718 976 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0200089 500 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0200683 574 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0202205 300 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0202205 398 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0202513 699 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0202920 385 HLA4/5 Abut, Hex-Lock, 4.5mm Imp, 5.5 Flare 0204711 399 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 013590 400 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 015270 240 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 015939 299 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 016765 312 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 0201607 300 HLA4/6 Abut, Hex-Lock, 4.5mm Imp, 6.5 Flare 0202514 148 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 013321 153 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 013833 400 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 014047 598 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 015392 597 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 016737 536 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 017758 595 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 0200798 499 HLA4G Abut, Gold, Friction-Fit, 4.5mm Imp 0201608 300 HLA4T Abut, Ti, Friction-Fit, 4.5mm Imp 013171 197 HLA4T Abut, Ti, Friction-Fit, 4.5mm Imp 016750 200 HLA4T Abut, Ti, Friction-Fit, 4.5mm Imp 0201255 50 HLA4T Abut, Ti, Friction-Fit, 4.5mm Imp 0202515 50 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 013357 177 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 013357 98 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 013357 4 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 014478 400 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 015158 357 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 016531 600 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 016959 300 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 0200282 261 HLA5/6 Abut, Hex-Lock, 5.7mm Imp, 6.5 Flare 0202948 500 HLA5G Coping, Gold, Eng, 5.7 mm Imp 016559 194 HLA5G Coping, Gold, Eng, 5.7 mm Imp 0200090 149 HLA5G Coping, Gold, Eng, 5.7 mm Imp 0200945 48 HLA5G Coping, Gold, Eng, 5.7 mm Imp 0201332 134 HLT3/3 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 3.5mm Flare 013084 294 HLT3/3 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 3.5mm Flare 015119 250 HLT3/3 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 3.5mm Flare 017289 300 HLT3/3 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 3.5mm Flare 0200634 150 HLT3/3 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 3.5mm Flare 0201948 153 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 015555 599 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 016351 500 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 017122 400 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 0201258 297 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 0202047 294 HLT3/4 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 4.5mm Flare 0204457 397 HLT3/5 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 5.5mm Flare 014959 252 HLT3/5 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 5.5mm Flare 0201518 100 HLT3/5 Xfr, Hex, Indirect, Scr-V, 3.5mm Imp, 5.5mm Flare 0202423 100 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 014607 293 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 015556 246 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 016683 300 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 017249 298 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 0201259 200 HLT4/4 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 4.5mm Flare 0202574 198 HLT4/5 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 5.5mm Flare 014960 296 HLT4/5 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 5.5mm Flare 016645 275 HLT4/5 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 5.5mm Flare 0201609 100 HLT4/5 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 5.5mm Flare 0202062 75 HLT4/5 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 5.5mm Flare 0202516 92 HLT4/6 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 6.5mm Flare 015780 80 HLT4/6 Xfr, Hex, Indirect, Scr-V, 4.5mm Imp, 6.5mm Flare 0201610 40 HLT5/6 Xfr, Hex, Indirect, Scr-V, 5.7mm Imp, 6.5mm Flare 0203917 99 HLTE Xfr, Indirect, Int Hex Imp, Scr-V, 3mm Extension 013172 100 HLTE Xfr, Indirect, Int Hex Imp, Scr-V, 3mm Extension 014944 105 HLTS2 Scr, Replace, Hex-Lock Abut, Int Hex Imp 013937 500 HSI2 HEXED/SQUARE INSERT 013309 239 HSI2 HEXED/SQUARE INSERT 014526 199 HSI2 HEXED/SQUARE INSERT 015557 299 HSI2 HEXED/SQUARE INSERT 016767 100 HX1.25 Tool, Hex, SST, 1.25mm, 17mm 013181 486 HX1.25 Tool, Hex, SST, 1.25mm, 17mm 015097 800 HX1.25 Tool, Hex, SST, 1.25mm, 17mm 016352 400 HX1.25 Tool, Hex, SST, 1.25mm, 17mm 016768 600 HX1.25D Drill, 1.25mm Hex, SST 011924 199 HX1.25D Drill, 1.25mm Hex, SST 013182 257 HX1.25D Drill, 1.25mm Hex, SST 014584 395 HX1.77 Tool, Hex, SST, ''TS'' Series Inserts, 15mm 013183 80 HX2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 15mm, SST 014156 300 HX2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 15mm, SST 014815 589 HX3.0D Drill, Hex, Stainless Steel, 3mm 014406 150 HX3.0D Drill, Hex, Stainless Steel, 3mm 015480 79 HX3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 15mm, SST 013184 255 HX3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 15mm, SST 015125 149 HX3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 15mm, SST 015967 200 HX3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 15mm, SST 016771 284 HXL1.25 Tool, Hex, SST, 1.25mm, 22mm 013346 508 HXL1.25 Tool, Hex, SST, 1.25mm, 22mm 014961 500 HXL1.25 Tool, Hex, SST, 1.25mm, 22mm 015940 498 HXL1.25 Tool, Hex, SST, 1.25mm, 22mm 016772 700 HXL2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 26mm, SST 012707 341 HXL2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 26mm, SST 014610 395 HXL2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 26mm, SST 015941 297 HXL2.5-S Tool, Hex, 2.5mm Hex, Sq Conn, 26mm, SST 016773 300 HXL3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 26mm, SST 014159 435 HXL3.0-S Tool, Hex, 3mm Hex-Hole Sq Conn, 26mm, SST 016644 198 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 012717 599 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 013185 600 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 013404 690 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 013405 691 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 013561 694 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 013750 799 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 014090 800 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 014407 699 IA3 Analog, Imp, 3.5mm Imp, 2.5mm Hex 014412 697 IA4 Analog, Imp, 4.5mm Imp, 2.5mm Hex 013186 600 IA4 Analog, Imp, 4.5mm Imp, 2.5mm Hex 013562 700 IA4 Analog, Imp, 4.5mm Imp, 2.5mm Hex 014044 799 IA4 Analog, Imp, 4.5mm Imp, 2.5mm Hex 014490 500 IA5 Analog, Imp, 5.7mm Imp, 3mm Hex 013443 412 IA5 Analog, Imp, 5.7mm Imp, 3mm Hex 014328 300 IRT Tool, Implant Removal, Scr Type Imp 014973 50 MHLAS Scr, Replace, Friction-Fit Gold & Ti Abut, Int Hex 013085 490 MHLAS Scr, Replace, Friction-Fit Gold & Ti Abut, Int Hex 013934 600 MPSU/4 Sheath, Friction-Fit Abut & Collar Cpng, 4.5mm Fla 016960 50 MTWSD SCREW,WAXING POST,GOLD 013470 150 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 015655 150 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 015656 148 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 017724 27 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 0200114 247 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 0200800 150 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 0201530 99 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 0202052 98 NEA3G Coping,Gold, Non-Eng.,3.5 mm Imp 0202554 200 NEA4G Coping,Gold, Non-Eng.,4.5 mm Imp 015657 148 NEA4G Coping,Gold, Non-Eng.,4.5 mm Imp 0200115 147 NEA4G Coping,Gold, Non-Eng.,4.5 mm Imp 0202556 100 PIMTB Tool, Plastic Tip 012932 49 PIMTB Tool, Plastic Tip 015559 50 PPAR Tool, Paralleling Instrument 011975 404 PPAR Tool, Paralleling Instrument 012725 569 PPAR Tool, Paralleling Instrument 013751 365 PPAR Tool, Paralleling Instrument 014493 700 PPAR Tool, Paralleling Instrument 015120 800 PPAR Tool, Paralleling Instrument 015970 799 PSO Sheath, Castable, Plastic, Straight Abut, TSI Seri 014494 400 PSO Sheath, Castable, Plastic, Straight Abut, TSI Seri 015949 300 PSO Sheath, Castable, Plastic, Straight Abut, TSI Seri 016753 250 PSO1 Sheath, Castable, Plastic, Tapered Abut, TSI Serie 015322 125 SCA1 Abut, 20 deg, Spectr-Angle, Scr-V, 3.5mm, 2mm 012093 99 SCA1 Abut, 20 deg, Spectr-Angle, Scr-V, 3.5mm, 2mm 015825 37 SCA1 Abut, 20 deg, Spectr-Angle, Scr-V, 3.5mm, 2mm 016234 48 SCA1 Abut, 20 deg, Spectr-Angle, Scr-V, 3.5mm, 2mm 016989 69 SCAW1 Abut, 20 deg, Spectra-Angle, Scr-V, 4.5mm, 2mm 016439 30 SCAW2 Abut, 20 deg, Spectra-Angle, Scr-V, 4.5mm, 3.5mm 0202167 9 SCC1 Abut, Spectra-Cone, Scr-V, 3.5mm, 0.75mm 014945 35 SCC1 Abut, Spectra-Cone, Scr-V, 3.5mm, 0.75mm 015813 150 SCC1 Abut, Spectra-Cone, Scr-V, 3.5mm, 0.75mm 016354 150 SCC2 Abut, Spectra-Cone, Scr-V, 3.5mm, 2mm 015815 37 SCC2 Abut, Spectra-Cone, Scr-V, 3.5mm, 2mm 016236 147 SCC2 Abut, Spectra-Cone, Scr-V, 3.5mm, 2mm 0202051 50 SCCW1 Abut, Spectra-Cone, Scr-V, 4.5mm, 0.75mm 014735 99 SCCW1 Abut, Spectra-Cone, Scr-V, 4.5mm, 0.75mm 016722 50 SCCW1 Abut, Spectra-Cone, Scr-V, 4.5mm, 0.75mm 0200288 50 SCCW2 Abut, Spectra-Cone, Scr-V, 4.5mm, 2mm 0200289 49 SCCW2 Abut, Spectra-Cone, Scr-V, 4.5mm, 2mm 0202337 40 SCDT/4 Transfer, Direct, Spectra-Cone Abut, 4.5mm Flare 015324 109 SCDT/4 Transfer, Direct, Spectra-Cone Abut, 4.5mm Flare 016183 198 SCDT/4 Transfer, Direct, Spectra-Cone Abut, 4.5mm Flare 0202689 49 SCGC Coping, Spectra-Cone, Gold, Non-Hexed 013216 291 SCGC Coping, Spectra-Cone, Gold, Non-Hexed 015088 299 SCGC Coping, Spectra-Cone, Gold, Non-Hexed 017493 191 SCGC Coping, Spectra-Cone, Gold, Non-Hexed 0201006 149 SCGC Coping, Spectra-Cone, Gold, Non-Hexed 0202234 99 SCGCH Coping, Spectra-Cone, Gold, Hexed 013923 98 SCGCH Coping, Spectra-Cone, Gold, Hexed 0201007 50 SCGCH Coping, Spectra-Cone, Gold, Hexed 0202338 30 SCHST Tool, Seating, Spectra-Cone Abut 015325 50 SCIT/4 Transfer, Indirect, Spectra-Cone Abut, 4.5mm Flare 014495 50 SCIT/4 Transfer, Indirect, Spectra-Cone Abut, 4.5mm Flare 016069 50 SCIT/4 Transfer, Indirect, Spectra-Cone Abut, 4.5mm Flare 016778 50 SCPC Coping, Plastic, Spectra-Cone Abut 016166 48 SCPC Coping, Plastic, Spectra-Cone Abut 016356 52 SCR Replica, Spectra-Cone Abutment 013279 350 SCTC ABUT,UNI,SPECTRA-CONE,CLR 016967 49 SCTHC/5 Cap, Healing, Ti, Spectra-Cone Abut, 5.5mm Flare 0201183 30 SCTS Scr, Fixation, Replace, Spectra-Cone & Tapered Abu 012651 300 SCTS Scr, Fixation, Replace, Spectra-Cone & Tapered Abu 013753 397 SCTS Scr, Fixation, Replace, Spectra-Cone & Tapered Abu 015121 697 SCTT Ti Temporary, Spectra-Cone & Spectra-Angle 015341 150 SCTT Ti Temporary, Spectra-Cone & Spectra-Angle 015785 43 SCTT Ti Temporary, Spectra-Cone & Spectra-Angle 016779 51 SCTT Ti Temporary, Spectra-Cone & Spectra-Angle 0201008 50