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Showing 20861–20880 of 22584 results

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Hill-Rom, Inc.: Hill-Rom CareAssist Bed; model P1170.

Warning label containing instructions for proper electrical grounding was not attached.

FDANov 29, 2004Nationwide• Hill-Rom, Inc.

Arrow International Inc: NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term...

complaints of vessel erosion when using this product

FDANov 24, 2004Nationwide• Arrow International Inc

AGA Medical Corporation: AMPLATZER Exchange System 45-degree curve, order no. 9-EX...

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDANov 23, 2004Nationwide• AGA Medical Corporation

AGA Medical Corporation: AMPLATZER Delivery System 180-degree curve, order no. 9-D...

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDANov 23, 2004Nationwide• AGA Medical Corporation

AGA Medical Corporation: AMPLATZER Delivery System 45-degree curve, order no. 9-DE...

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDANov 23, 2004Nationwide• AGA Medical Corporation

AGA Medical Corporation: Amplatzer Delivery Systems (45-degree curve). order no. ...

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDANov 23, 2004Nationwide• AGA Medical Corporation

AGA Medical Corporation: AMPLATZER Exchange System 180-degree curve, order no. 9-E...

Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.

FDANov 23, 2004Nationwide• AGA Medical Corporation

DeRoyal Technologies Inc: Cold Therapy Blanket

There is a possibility of water leaking from the welded seam of the blanket.

FDANov 22, 2004Nationwide• DeRoyal Technologies Inc

Ekos Corp: Lysus Infusion System - Lysus Drug Delivery Catheter: ...

During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered

FDANov 22, 2004AZ, CA, FL +4 more• Ekos Corp

Ortho-Clinical Diagnostics: Vitros CRP (C-Reactive Protein) Slides. Catalog #192 674...

Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.

FDANov 22, 2004Nationwide• Ortho-Clinical Diagnostics

Boston Scientific Corporation: VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UN...

Catheter separation immediately distal to the nose of the suture wing.

FDANov 22, 2004IN• Boston Scientific Corporation

Boston Scientific Corporation: PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEAL...

Catheter separation immediately distal to the nose of the suture wing.

FDANov 22, 2004IN• Boston Scientific Corporation

Boston Scientific Corporation: VAXCEL PASV Peripherally Inserted Central Catheter, 3F, s...

Catheter separation immediately distal to the nose of the suture wing.

FDANov 22, 2004IN• Boston Scientific Corporation

Boston Scientific Corporation: PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIV...

Catheter separation immediately distal to the nose of the suture wing.

FDANov 22, 2004IN• Boston Scientific Corporation

Stryker Howmedica Osteonics Corp.: Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And ...

The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.

FDANov 22, 2004Nationwide• Stryker Howmedica Osteonics Corp.

Ethicon Endo-Surgery: Endopath EZ45 No Knife Linear Stapler (NK45B).

The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

FDANov 21, 2004Nationwide• Ethicon Endo-Surgery

Ethicon Endo-Surgery: Endopath EZ45 Endoscopic Linear Cutter (EZ45B)

The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

FDANov 21, 2004Nationwide• Ethicon Endo-Surgery

Medtronic Inc, Neurological & Spinal Division: Model 8561 Lioresal (Baclofen injection) Intrathecal Refi...

Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).

FDANov 19, 2004Nationwide• Medtronic Inc, Neurological & Spinal Division

Pulmonetic Systems, Inc.: Universal Cable Adaptor (Part #17765-001 and labeled on o...

Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

FDANov 19, 2004Nationwide• Pulmonetic Systems, Inc.

Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.

A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.

FDANov 19, 2004Nationwide• Roche Diagnostics Corp.

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