DECEMBER 2003

WEEK ENDING DECEMBER 6

Respironics Issues Voluntary Recall of ComfortGel® Mask

Respironics, Inc. (NASDAQ/NMS Symbol: RESP) has voluntarily recalled 5,293 ComfortGel® nasal masks distributed from September 5, 2003 through September 15, 2003. These nasal masks, which were part of Respironics initial launch of the ComfortGel Mask, have been recalled because the company discovered that some masks shipped to Home Health Care Providers or distributors did not contain a built-in exhalation port. The exhalation port is required to allow exhaled air to properly exhaust. The masks were shipped without the exhaust port used to exhaust all of the exhaled CO2, which potentially could result in patients re-breathing CO2, associated decreased oxygen levels and increased CO2 levels in the blood. The ComfortGel nasal mask can only be obtained through a physician prescription.

The ComfortGel masks are used in the treatment of Obstructive Sleep Apnea (OSA) in conjunction with a Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (Bi-PAP) device which supplies a continuous stream of air which keeps the patient’s airway open during sleep to diminish apnea, or awakening, episodes.

A corrective action was begun immediately in which Respironics contacted all customers who were shipped masks during the September 5 to September 15 timeframe. The company has completed contact with all customers who received shipments of the masks and will continue inspection and replacement efforts until all suspected masks are returned by customers. As of today, 82% of the recalled masks have been returned to Respironics and less than 3% have been determined to be affected.

Respironics will work closely with the FDA to ensure that all masks in question are returned to the company for thorough inspection and repair or replacement.

Respironics, Inc. is notifying its distributors and customers by telephone and written communication and is arranging for return of all recalled products. Consumers with questions may contact the company at 1-800-345-6443.

PRODUCT Coulter DNA Prep Reagents Kit Part 6607055.

CODE Lot # 760203k-760208k, 760213k, 760218k.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Labeling Error-Omission of "Research Use Only".
VOLUME OF PRODUCT IN COMMERCE 284.
DISTRIBUTION Nationwide and Canada.

PRODUCT
a) Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if package is unopened or undamaged.

Part # IN2125/B

b) IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: "NTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL" Latex free. Sterile if package is unopened or undamaged. Part # 1525/B.
c) VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''.
Sterile if package is unopened or undamaged. Part #VAC160.
d) Inflation Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K05-10570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D,
K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,

K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,
K05-00180G, and K05-00553F.
e) Manifold Custom Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged.

Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-00970J, #K09-06383B, #K09-07002A, #K09-04734D, #K09-00794K,

and #K09-08037A.
f) Waste Collection Kit. Label reads in part: "CUSTOM KIT...MERIT MEDICAL". Latex free, Sterile if package is unopened or undamaged.

Part # K10-01047.
CODE
a) Lot # A284004 and Lot # A287115;
b) Lot # A285003;
c) Lot # A282003;
d) Lot # A286536 # A286573 #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538, #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616 #A284618, #A286535, #A286547, #A284998 #A284694, #A284617, #A286560,
#A286542 #A286550, #A287554, #A287553, #A279791, #A290033, #A290053, #A286541, and #A283067;
e) Lot # A279212, #A28360, #A286211, #A282726 #A281641, #A279931, #A282796, #A288051, #A285173, #A284256, and #A290244;
f) Lot # A289183.
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT.
REASON There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
VOLUME OF PRODUCT IN COMMERCE 11,022 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230).
CODE Serial numbers: 01AGJ199, 01AGJ262, 01DGJ251, 01EGJ125, 01JGJ177, 01MGJ243, 02CGJ244, 02EGJ160, 02EGJ311 and 02LGJ211.
RECALLING FIRM/MANUFACTURER ConMed Electrosurgery, Centennial, CO.
REASON The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA, CT, IL, ME, and the Phillipines.

PRODUCT Portable Oxygen Analyzer.

CODE Model # AX300, MX300.
RECALLING FIRM/MANUFACTURER Teledyne Analytical Instruments, Rowland Heights, CA.
REASON Potential failure to display the battery low light to the end-user.
VOLUME OF PRODUCT IN COMMERCE 170.
DISTRIBUTION FL, CA, UT, AZ, MO, New Zeland, Australia, Canada and the United Kingdom.

PRODUCT
a) KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
b) KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
CODE
a) Lot nos. A284998, A282736, A284998, A282736;
b) Lot No. 03090901, Lot No. 03090902, Lot No. 03090903, Lot No. 03091704, Lot No. 03091705, Lot No. 03090807, Lot No. 03090806.
RECALLING FIRM/MANUFACTURER Kyphon, Inc., Sunnyvale, CA.
REASON Devices for which sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE 982 syringes.
DISTRIBUTION Nationwide.

PRODUCT 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set. Catalog/Model number CL-07011.
CODE Lot number CF03075226.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, Pa.
REASON Package lid identifies the contents incorrectly.
VOLUME OF PRODUCT IN COMMERCE 80 kits.
DISTRIBUTION AR, CA, NH, VA, VT and Srialanka.

PRODUCT
a) ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000.
b) Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001.
c) Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use. Product Number: 780A.
d) DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use Product Numbner; P012-180A.
e) Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use. Product Number: 014-180A.
f) Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution.
CODE
a) Lot Number: B020122B;
b) Lot Number: B020122E;
c) Lot Numbers: B0201222, B020122D, B020122G;
d) Lot Numbers: B020122A, B020122J;
e) Lot Number: B020122H;
f) Lot Numbers: B020122C, B020122F.
RECALLING FIRM/MANUFACTURER Anika Therapeutics, Woburn, MA.
REASON Stability failure at the 20 month for viscosity specification.
VOLUME OF PRODUCT IN COMMERCE 40,698 units.
DISTRIBUTION CA, MO, NC, and VA.

PRODUCT CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939.
CODE Lot Numbers: 23095A, 23340A, and 30116A.
RECALLING FIRM/MANUFACTURER Ventana Medical Systems, Inc., Tucson, AZ.
REASON Increased level of non-specific or background staining.
VOLUME OF PRODUCT IN COMMERCE 95.
DISTRIBUTION Nationwide, Japan, France and Puerto Rico.

PRODUCT Datex-Ohmeda Cardiocap/5 Patient Monitors.
CODE The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product.
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Inc., Madison, WI.
REASON Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
VOLUME OF PRODUCT IN COMMERCE 875 units.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING DECEMBER 13

PRODUCT Calculator/Data Processing Module for Clinical Use.

CODE Versions 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software defect. Clinical Laboratory results failing quality assurance were filed directly to a patient's chart without review.
VOLUME OF PRODUCT IN COMMERCE 479.
DISTRIBUTION Nationwide and Internationally.

PRODUCT FastPack Total Testosterone Immunoassay. Device to determine quantitative total testosterone in human serum.

Catalog #: 25000009
CODE Lots: 0307042, 0308019, and 0308020.
RECALLING FIRM/MANUFACTURER Qualigen Inc., Carlsbad, CA.
REASON Kits may produce results that are falsely elevated.
VOLUME OF PRODUCT IN COMMERCE 81.
DISTRIBUTION Nationwide and Switzerland.

PRODUCT Misys Laboratory System.
CODE Versions 5.2, 5.23, 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.
VOLUME OF PRODUCT IN COMMERCE 473.
DISTRIBUTION Nationwide and Internationally.

PRODUCT 100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102.
CODE Lots D316302 and D323912.
RECALLING FIRM/MANUFACTURER Maximus Medical Products Inc, Costa Mesa, CA,
REASON Mislabeled with wrong drop size drip chamber specification.
VOLUME OF PRODUCT IN COMMERCE 63 cases.
DISTRIBUTION CO, and PA.

PRODUCT
a) Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection),catalog #790044.
b) Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T.
c) Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000.
d) Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042.
CODE
a) Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52038725 through 52429358. Not all units in the serial number range were affected. 230 units were sold new with affected chucks and 259 units were repaired with the affected chucks.
b) Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52336288 through 52429923. Not all units in the serial number range were affected. 446 units were sold new with affected chucks and 252 units were repaired with the affected chucks.
c) Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 60007550, 60009370, 110298025 and 600000215 through 600018298. Not all units in the serial number range were affected. 388 units were repaired with the affected chucks.

d) Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52327547, 52343124, 52372259, 52417392.
RECALLING FIRM/MANUFACTURER DentSply-Professional Division, Des Plaines, IL.
REASON Small Cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
VOLUME OF PRODUCT IN COMMERCE 1,579 chuck assemblies.
DISTRIBUTION Nationwide, Canada and Mexico.

PRODUCT
a) UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Catalog Number7779-10.

b) UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Catalog Number 5614-A0.
CODE
a) Lots G270628, G283744, G260778;
b) Lot G260778.
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc, South Jordan, UT.
REASON Angiographic catheter tips may separate during use.
VOLUME OF PRODUCT IN COMMERCE 442 units.
DISTRIBUTION FL, MI, NY, PA, TN, and TX.

PRODUCT
a) Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. Catalog number SP01.
b) Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle. Catalog number SP02.
CODE
a) Lot numbers H0359, J0107, and J0493;
b) Lot numbers H0266, H0464, H0565, H0650, I0195, J0288, J0108, J0494, K0701, and K0929.
RECALLING FIRM/MANUFACTURER Vygon US LLC, Norristown, PA.
REASON Mislabeled as sterile.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION NY, TX, UT, and Internationally.

PRODUCT URO PRO Plus Digital Urology Imaging System.
CODE Serial Numbers: UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03.
RECALLING FIRM/MANUFACTURER Medstone International, Inc., Aliso Viejo, CA.
REASON X-ray tube arm and collimator fell and fractured patient's ribs.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NM, NV, WA, and CA.

PRODUCT ICON 25 hCG Test Kit.
CODE Lot hCG030303.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON False negative urine results are being observed at an increasing rate.
VOLUME OF PRODUCT IN COMMERCE 9,040.
DISTRIBUTION Nationwide and Canada.

PRODUCT AEROSET Immunoglobulin M, list number 1E01-01.
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div., South Pasadena, CA,
REASON Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.
VOLUME OF PRODUCT IN COMMERCE 205.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine. Catalog Number: 15545-20.

CODE Lot number: K203631 Exp. Date: 2004-08.
RECALLING FIRM/MANUFACTURER Portex Inc., Keene, NH.
REASON Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
VOLUME OF PRODUCT IN COMMERCE 2,600 units.
DISTRIBUTION Nationwide.

PRODUCT CeyoValve Pulmonary Valve & Conduct. Model Number PV00.
CODE Serial Number 8041312.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.

PRODUCT Paradigm Model 511 Insulin Infusion Pumps.
CODE All.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA.
REASON Water ingresses into the device when in prolonged contact with water causing device to malfunction.
VOLUME OF PRODUCT IN COMMERCE 61,000.
DISTRIBUTION Nationwide and Canada.

PRODUCT Ambulatory infusion pump. Model 511.
CODE All.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA.
REASON Non delivery of insulin by pump after electrostatic discharge.
VOLUME OF PRODUCT IN COMMERCE 17,000.
DISTRIBUTION Nationwide, Canada and possibly International.

WEEK ENDING DECEMBER 20

PRODUCT
a) ComfortGel Nasal Mask size small.
b) ComfortGel Nasal Mask size medium.
c) ComfortGel Nasal Mask size large.
CODE
a) Part number 1009041; Lot numbers 030612, 130418, 030417, 030415,030409, 030321, 030320, 030316, 030312, 030311, 030310, 030306, 030305, 030303, and 030228;
b) Part number 1009042; Lot numbers 030604, 030603, 030528, 030520, 030501, 030422, 030421, 030408,030325, 030319, 030314, 030312, 030311, 030227, 030226, 020826, and 020823;
c) Part number 1009043; Lot numbers 030826, 030814, 030528, 030307, and 020822.
RECALLING FIRM/MANUFACTURER Respironics, Inc., Murrysville, PA.
REASON Product does not contain built in exhalation port.
VOLUME OF PRODUCT IN COMMERCE 72 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT TC-PLUS Solution Femoral Component Size 12L, part 21041-C.
CODE Lot 0006.13.2635.
RECALLING FIRM/MANUFACTURER Plus Orthopedics, San Diego, CA.
REASON Inaccurate dimensions of the device.
VOLUME OF PRODUCT IN COMMERCE 5.
DISTRIBUTION TX.

PRODUCT Stryker brand Ortho Tec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
CODE Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
RECALLING FIRM/MANUFACTURER Stryker Instruments, Instruments Div., Kalamazoo, MI.
REASON Product sterility may have been compromised by an inadequate package seal.
VOLUME OF PRODUCT IN COMMERCE 296 boxes.
DISTRIBUTION Nationwide, France and United Kingdom.

PRODUCT AxSYM Analyzer, Small Heater Block Clamp.
CODE All Serial Numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.
VOLUME OF PRODUCT IN COMMERCE 15,437.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
CODE Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163 Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC Bed package model numbers which include the affected Beds and foot sections: BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.
RECALLING FIRM/MANUFACTURER Invacare Corporation, Elyria, OH.
REASON Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
VOLUME OF PRODUCT IN COMMERCE 5,926.
DISTRIBUTION Nationwide and Canada.

PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder.
CODE Versions 6.1 and 6.5.
RECALLING FIRM/MANUFACTURER Varian Brachytherary Virginia, Charlottesville, VA.
REASON The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to the patient.
VOLUME OF PRODUCT IN COMMERCE 29 sets.
DISTRIBUTION Nationwide and Internationally.

PRODUCT CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; 24 units per case.
CODE Lot numbers A00K09, exp 10/2003; A01C04, exp 2/2004; C01A08, exp 12/2003; E01B15, exp 1/2004.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON Use of the dialyzers may cause iritis (red eye) patient reactions.
VOLUME OF PRODUCT IN COMMERCE 34,865 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X.
CODE The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
RECALLING FIRM/MANUFACTURER Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN.
REASON Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
VOLUME OF PRODUCT IN COMMERCE 707 strollers.
DISTRIBUTION Nationwide, Canada, and Mexico.

PRODUCT
a) Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A.
b) Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1.
c) Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A.
CODE
a) S/N''S: R00043, R001080, R001092, R001198, R0001341, R001370, R001374, R001366, R001337, R001497, R001478, R001493, R001501, R001529, R001812, R001816, R002023;
b) Serial Numbers: 217335, 214331.
c) Serial Number: 192478.
RECALLING FIRM/MANUFACTURER The OR Group, Acton, MA.
REASON Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb.
VOLUME OF PRODUCT IN COMMERCE 20.
DISTRIBUTION Nationwide.

PRODUCT
a) Ross 14 FR Gastrostomy Tube, Item # 152.
b) Ross 16 FR Gastrostomy Tube, Item # 153.
c) Ross 18 FR Gastrostomy Tube, Item # 154.
d) Ross 20 FR Gastrostomy Tube, Item # 155.
e) Ross 22 FR Gastrostomy Tube, Item # 156.
f) Ross 24 FR Gastrostomy Tube, Item # 159.
g) Ross 26 FR Gastrostomy Tube, Item # 50158.
h) Ross 16 FR Easy-Feed Gastrostomy Tube, Item # 50112.
i) Ross 18 FR Easy-Feed Gastrostomy Tube, Item # 50114.
j) Ross 20 FR Easy-Feed Gastrostomy Tube, Item # 50116.
k) Ross 22 FR Easy-Feed Gastrostomy Tube, Item # 50118.
l) Ross 14 FR Magna-Port Gastrostomy Tube, Item # 51358.
m) Ross 16 FR Magna-Port Gastrostomy Tube, Item # 51360.
n) Ross 18 FR Magna-Port Gastrostomy Tube, Item # 51362.
o) Ross 20 FR Magna-Port Gastrostomy Tube, Item # 51364.
p) Ross 22 FR Magna-Port Gastrostomy Tube, Item # 51366.
q) Ross 24 FR Magna-Port Gastrostomy Tube, Item # 54738.
r) Ross 28 FR Magna-Port Gastrostomy Tube, Item # 54736.
s) Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item # 50190.
t) Ross 22 FR Versa-PEG Gastrostomy Kit, Item # 50520.
u) Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown Mueller T-Fastener Set, Item # 51174.
CODE
a) Lot Numbers: 03590GZ00, 91083GZ00, 92185GZ00, 95422GZ00;
b) Lot Numbers: 02550GZ00, 91051GZ00, 92181GZ00, 94375GZ00, 96457GZ00;
c) Lot Numbers: 01502GZ00, 04632GZ00, 05667GZ00, 05686GZ00, 89877GZ00, 90981GZ00, 91104GZ00, 92182GZ00, 92213GZ00, 95409GZ00;
d) Lot Numbers: 02551GZ00, 03614GZ00, 89972GZ00, 91052GZ00, 91155GZ00, 92214GZ00, 95396GZ00, 96463GZ00;
e) Lot Numbers: 01523GZ00, 04654GZ00, 93288GZ00, 95423GZ00;
f) Lot Numbers: 04635GZ00, 90012GZ00, 92186GZ00, 96439GZ00, 87767GZ00;
g) Lot Numbers: 02541GZ00, 91163GZ00, 96458GZ00;
h) Lot Numbers: 02531GZ00, 90013GZ00;
i) Lot Numbers: 01494GZ00, 05692GZ00, 91069GZ00;
j) Lot Numbers: 01501GZ00, 06695GZ00, 93290GZ00;
k) Lot Numbers: 01512GZ00, 93291GZ00, 94336GZ00;
l) Lot Numbers: 05689GZ00, 92195GZ00, 96468GZ00;
m) Lot Numbers: 01520GZ00, 03615GZ00, 06710GZ00, 88835GZ00, 90983GZ00, 91074GZ00, 91129GZ00, 92212GZ00, 96442GZ00;
n) Lot Numbers: 02533GZ00, 04647GZ00, 05680GZ00, 91050GZ00, 91125GZ00, 92211GZ00, 95400GZ00, 96467GZ00;
o) Lot Numbers: 01519GZ00, 04641GZ00, 06708GZ00, 89960GZ00, 90029GZ00, 90046GZ00, 92194GZ00, 95397GZ00, 96462GZ00;
p) Lot Numbers: 01526GZ00, 06709GZ00, 93282GZ00;
q) Lot Numbers: 01507GZ00, 04636GZ00, 04663GZ00, 94349GZ00, 95425GZ00;
r) Lot Numbers: 92177GZ00, 95431GZ00;
s) Lot Numbers: 02565GZ00, 03600GZ00, 04643GZ00, 05676GZ00, 06719GZ00, 89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00, 93261GZ00, 94322GZ00 95410GZ00, 96470GZ00;
t) Lot Number: 01511GZ00;
u) Lot Numbers: 01528GZ00, 04666GZ00, 91053GZ00, 91157GZ00, 94377GZ00, 96466GZ00;
RECALLING FIRM/MANUFACTURER Ross Products Division, Abbott Laboratories, Columbus, OH.
REASON An increase in reported balloon failures, which may result in tube displacement.
VOLUME OF PRODUCT IN COMMERCE 210,846 (11,605 foreign).
DISTRIBUTION Nationwide, and Internationally.

WEEK ENDING DECEMBER 27

PRODUCT ARCHITECT Processing Module.
CODE All Serial numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
VOLUME OF PRODUCT IN COMMERCE 1,167 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.
CODE All units distributed between March 1997 and September 2003.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON The ambulatory assist bar may not lock into position and may come out of place due to incorrect assembly.
VOLUME OF PRODUCT IN COMMERCE 1,400.
DISTRIBUTION Nationwide and Canada.

PRODUCT Scopix( LR 5200P( Laser Imagers, Type 8394/600, Model number LR 5200P, Catalog number EMQT S000.
CODE Types: 8394/600, Serial numbers: 4000 through 5266.
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC.
REASON The GS1 circuit board may fail resulting in smoke or fire.
VOLUME OF PRODUCT IN COMMERCE 115 units.
DISTRIBUTION Nationwide.

PRODUCT Aeroset Phenobarbital, LN 1E08-01.
CODE Lots: 01066HW00 expires 10/31/2003, 06030HW00 expires 4/30/2004, 08060HW00 expires 7/31/2004.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div., South Pasadena, CA.
REASON Assay is imprecise.
VOLUME OF PRODUCT IN COMMERCE 112.
DISTRIBUTION Nationwide, Mexico, England and Canada.

PRODUCT Exacta-Mix 2400 pharmacy compounding system.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Baxa Corp, Englewood, CO.
REASON If device stops due to an alarm or operator pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber
VOLUME OF PRODUCT IN COMMERCE 231 systems.
DISTRIBUTION Nationwide, and UK.

PRODUCT C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm. Catalog # 1100-9019 & # 1100-9020.
CODE Lot #25947.
RECALLING FIRM/MANUFACTURER Interpore Cross International, Inc., Irvine, CA.
REASON Step drills from Lot 25947
VOLUME OF PRODUCT IN COMMERCE 433.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Konica Minolta Duplicating Film Emulsions, Konica Medical Film. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only. SR-DUP C 14x17.
CODE Emulsion numbers (X=any number): X742, X842, X152, and X023.
RECALLING FIRM/MANUFACTURER Konica Medical Imaging, Inc., Wayne, NJ.
REASON Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
VOLUME OF PRODUCT IN COMMERCE 4,383.
DISTRIBUTION Nationwide.

PRODUCT Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalog #221267, packaged in cardboard carton, 100 plates per carton
CODE
Lot/EXP 3197678/November 13, 2003; 3197693/November 14, 2003; 3198565/November 07, 2003; 3212853/November 25, 2003; 3212901/November 27, 2003; 3212919/November 28, 2003; 3212956/December 02, 2003; 3212972/December 03, 2003.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Co., Sparks, MD.
REASON Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.
VOLUME OF PRODUCT IN COMMERCE 7,302 cartons.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and 7106557.
CODE Software version VA21C.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
VOLUME OF PRODUCT IN COMMERCE 118 units.
DISTRIBUTION Nationwide.

PRODUCT
Architect Anti-HBs Reagent Kit:
a) list 7C18-20, 4x100 tests;
b) list 7C18-25, 100 tests.
CODE
a) Lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004;
b) Lot 07779M301, exp 06/19/2004.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
VOLUME OF PRODUCT IN COMMERCE 2,244 kits.
DISTRIBUTION Canada, Japan, Australia, New Zealand, Germany and England.

PRODUCT
a) Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion.

Reference: 8888-135192.
b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195.
CODE
a) Lot Number: 140885;
b) Lot Number: 140774.
RECALLING FIRM/MANUFACTURER Kendall Healthcare Products Co, Mansfield, MA.
REASON Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm.
VOLUME OF PRODUCT IN COMMERCE 55 catheters.
DISTRIBUTION IL, MA, OH, TN, TX, VA.