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Showing 21401–21420 of 22584 results

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Dynex Technologies, Inc.: Pipette Sample Tip, Product part #65910, packaged in card...

An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.

FDAJun 11, 2004IN• Dynex Technologies, Inc.

Encision, Inc.: AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

Electrosurgical tip may break or come off during use.

FDAJun 11, 2004AL, CT, GA +8 more• Encision, Inc.

Abbott Laboratories HPD/ADD/GPRD: ABBOTT TestPack+Plus Strep A with On Board Controls (OBC)...

False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control.

FDAJun 11, 2004IN• Abbott Laboratories HPD/ADD/GPRD

Gen Probe Inc: Gen-Probe Amplified Mycobacterium Tuberculosis Direct Tes...

Reduced stability

FDAJun 11, 2004Nationwide• Gen Probe Inc

Cook, Inc.: Cook brand Keller-Timmermans Introducer Set, straight wit...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Cook, Inc.: Cook brand Zenith AAA Converter with the H&L-B One-Shot I...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Abbott Laboratories, Inc: ARCHITECT c8000 Processing Module; List Number 01G06-01. ...

Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.

FDAJun 10, 2004Nationwide• Abbott Laboratories, Inc

Cook, Inc.: Cook brand Zenith AAA Endovascular Graft Iliac Leg Extens...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Cook, Inc.: Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Tr...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Cook, Inc.: Cook brand Zenith AAA Bifurcated main body graft with the...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Cook, Inc.: Cook brand Zenith AAA Iliac leg graft with the H&L-B One-...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

Cook, Inc.: Cook brand Zenith rupture main body graft, preloaded graf...

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

FDAJun 10, 2004Nationwide• Cook, Inc.

bioMerieux: VIDAS CMV IgG Assay

The product may give false positive results.

FDAJun 9, 2004AR, CA, FL +20 more• bioMerieux

Philips Medical Systems Sales & Service Region No. America: MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 98...

When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

FDAJun 8, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Medtronic Vascular: Percutaneous Transluminal Coronary Angioplasty system in ...

medical device for which sterility may be compromised because of improper seal.

FDAJun 8, 2004Nationwide• Medtronic Vascular

Arjo, Inc.: Alenti Lift Hygiene Chair; a non-AC-powered patient lift;...

There has been an increased number of tipping incidents and subsequent patient injuries.

FDAJun 8, 2004Nationwide• Arjo, Inc.

Philips Medical Systems Sales & Service Region No. America: ViewForum Review Station Part Numbers: 9896 507 71830, ...

When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

FDAJun 8, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Welch Allyn Protocol, Inc: Welch Allyn Vital Signs Monitor 5300 Series 300 Part num...

Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.

FDAJun 8, 2004Nationwide• Welch Allyn Protocol, Inc

Philips Medical Systems Sales & Service Region No. America: EasyDiagnost Eleva Part Number 989605071921

When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.

FDAJun 8, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Lang Dental Mfg Co, Inc.: Ortho-Jet Powder, fast curing orthodontic acrylic resin; ...

The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

FDAJun 7, 2004Nationwide• Lang Dental Mfg Co, Inc.

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