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Showing 67981–68000 of 68218 results

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Abbott Laboratories HPD/ADD: 75-1650 Drip Chambers .138rr; Abbott, Ashland, Ohio 44805...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Invacare Corporation One Invacare Way: Invacare IVC Home Care Bed (Foot Section with new head ac...

Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.

FDAJun 9, 2003IN• Invacare Corporation One Invacare Way

Abbott Laboratories HPD/ADD: 96-8366 Drip Chambers, Convertible with Pierce Pin .138 ...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: I.V. Pump Sets with Cassettes for use with Abbott Plum Se...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: 96-8369 Micro Drip Chambers, Convertible with Pierce Pin ...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: I.V. Extension Sets; sterile, Rx, single use devices; Abb...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: Vented and Non-Vented Burette I.V. Gravity Feed Administr...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

MedAmicus, Inc: AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 ...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

MedAmicus, Inc: Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

MedAmicus, Inc: Medamicus FlowGuard 15FR Valved Peelable Introducer Kit,...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

A.R.C. Laser Corp: A.R.C. Laser Photolysis Probe/Handpiece

Product may not have been properly sterilized.

FDAJun 6, 2003IN, NY, PA +1 more• A.R.C. Laser Corp

Beckman Coulter Inc: IMMAGE IGALC Reagent Part Number: 447460

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

MedAmicus, Inc: AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 ...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

Kinetic Concepts, Inc: KinAir MedSurg, flotation therapy, powered hospital bed, ...

Weld failure causes side rail welds to turn upside down or break off of the bed.

FDAJun 6, 2003Nationwide• Kinetic Concepts, Inc

Beckman Coulter Inc: IMMAGE IGMLC Reagent Part Number: 447470

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: IMMAGE IgM Reagent Part No.: 447610

low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

MedAmicus, Inc: Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

MedAmicus, Inc: AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 ...

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

FDAJun 6, 2003GA, IN, MO +3 more• MedAmicus, Inc

ABX Diagnostics Inc: ABX Diagnostices Pentra 60C+ Hematology Analyzer

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

FDAJun 4, 2003Nationwide• ABX Diagnostics Inc

Safco Dental Supply Co. Inc.: Supergrade Earloop Masks, surgical mask; 50 masks per box...

The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

FDAJun 3, 2003Nationwide• Safco Dental Supply Co. Inc.

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