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Instrumentation Laboratory Co.: Lactate Disposable Membrane Caps Product Number: 0018108400

Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.

FDAAug 28, 2003IL, NY• Instrumentation Laboratory Co.

Hill-Rom Manufacturing, Inc.: FLEXICAIR MC3 Low Airloss Therapy unit

Reports of patient entrapment between mattress and side-rails.

FDAAug 27, 2003Nationwide• Hill-Rom Manufacturing, Inc.

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Instrumentation Laboratory Co.: Lactate Disposable Membrane Caps Product Number: 0018108400

Hill-Rom Manufacturing, Inc.: FLEXICAIR MC3 Low Airloss Therapy unit

Hill-Rom Manufacturing, Inc.: FLEXICAIR II, Low Airloss Therapy unit.This unit is simil...

Beckman Coulter Inc: Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-...

Surgical Specialties Corp: Brand name: Stylus 2-0 Polyviolene Double Armed with T Ta...

Bausch & Lomb Incorporated: Phaco Needles, catalog #DP8115, with 15 degree needle ta...

Bausch & Lomb Incorporated: Microflow Needles, catalog #DP8200, with 0 degree taperin...

I-Flow Corporation: Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x ...

Abbott Laboratories HPD/ADD/GPRD: AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced b...

Surgical Specialties Corp: Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Cle...

Unknown Manufacturer: Ace Percutaneous Transluminal Coronary Angioplasty (PTCA)...

Bard Peripheral Vascular Inc: Opti-Plast Balloon Dilatation Catheters

Olympus America Inc. Two: Brand name: Olympus ImageManager Software, Versions 6.0 t...

Abiomed, Inc.: BVS 5000t Bi-Ventricular Support System Transport/Backup ...

U & I America: Optima Large Poly Screw Driver

Wright Medical Technology Inc: Alumina ceramic liner for acetabular shell. This is part...

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit SG

Beckman Coulter Inc: Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

U & I America: Optima Poly Screw Driver.

Beckman Coulter Inc: Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Chol...