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Cryolife Inc: CryoValve Heart-valve, allograft

The recipient of one of the kidneys from the donor has developed renal cell carcinoma.

FDAMar 19, 2003IN, MS, NY• Cryolife Inc

Integra Life Sciences Corp.: Cranial Access Kit (INS-HITH) included in External CSF Dr...

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.

Moderate

FDAMar 19, 2003IN, NY• Integra Life Sciences Corp.

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Cryolife Inc: CryoValve Heart-valve, allograft

Integra Life Sciences Corp.: Cranial Access Kit (INS-HITH) included in External CSF Dr...

I-Flow Corporation: Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)

Medtronic, Inc.: Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH

Ciba Vision Corporation: Glitter Eyes (tefilcon), daily wear soft (hydrophilic) co...

Ossur North America Inc: Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM...

Unknown Manufacturer: Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm S...

Boston Scientific Corporation: Boston Scientific/Microvasive Open End Ureteral Catheter ...

Medtronic, Inc.: Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH

Deltec, Inc: Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Nu...

Roche Diagnostics Corp.: CoaguChek Plus meter; catalog # 475729 and 12816001.

Roche Diagnostics Corp.: CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

Canon USA Inc: Rational Imaging TM Software, model Ultra 10 PACS System...

Invacare Corp: Tarsys 1st Generation Seating System - an optional access...

Greiner VACUETTE North America: Vacuette, Safety Blood Collection Set with Luer Adapter

Instrumentation Laboratory Co.: GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reag...

Instrumentation Laboratory Co.: GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reag...

Permobile Inc.: Permobil Chairman 2K powered wheelchair

Steris Corp: C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olym...

Roche Molecular Systems Inc: COBAS TaqMan analyzer, Series 96; catalog number 8080216.