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Showing 66141–66160 of 68218 results

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Puritan Bennett: Puritan Bennett 840 Series Ventilator Power Supply Model...

Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.

FDAApr 20, 2005Nationwide• Puritan Bennett

Boston Scientific Scimed: PTFE (Polytetrafluoroethylene) felt. Catalog #s: M00200...

Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.

FDAApr 19, 2005Nationwide• Boston Scientific Scimed

Becton Dickinson & Company: BD #11 Bard Parker Scalpel. A general use surgical blade...

A small percentage of scalpels exhibited a 'double blade' condition.

FDAApr 19, 2005IL, IN, TN +4 more• Becton Dickinson & Company

Smiths Medical ASD, Inc.: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult ...

The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

FDAApr 19, 2005CA, IN, NC• Smiths Medical ASD, Inc.

Roche Diagnostics Corp.: Roche brand AccuData GTS/GTS Plus System Replacement Base...

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

GE Healthcare: GE Millennium Systems: MC, MyoSight. Dual Head Gamma Ca...

In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.

FDAApr 18, 2005Nationwide• GE Healthcare

Roche Diagnostics Corp.: Roche brand AccuData GTS Plus System; Catalog number 3000...

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

GE Healthcare: GE Millennium Systems: MPR and MPS Digital CSE Single De...

In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.

FDAApr 18, 2005Nationwide• GE Healthcare

GE Healthcare: GE Millennium Systems: MG. Multi-Geometry Digital CSE D...

In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.

FDAApr 18, 2005Nationwide• GE Healthcare

Ortho-Clinical Diagnostics: VITROS VALP Reagent , REF 680 1710. Each box contains 6 ...

Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.

FDAApr 18, 2005Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Roche brand AccuData GTS System; Catalog number 404, mate...

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

FDAApr 18, 2005Nationwide• Roche Diagnostics Corp.

Zimmer Inc.: Zimmer brand Versys Hip System Femoral Head 12/14 taper, ...

May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.

FDAApr 15, 2005Nationwide• Zimmer Inc.

Spinal Specialties, Inc: Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder...

Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.

FDAApr 15, 2005CA, FL, IL +3 more• Spinal Specialties, Inc

Stryker Howmedica Osteonics Corp.: Xcelerate Patella System Reamer Shaft Assembly; Non-Steri...

The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.

FDAApr 15, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Spinal Specialties, Inc: 22G Nerve Block PainPak, Reorder No.:3269, kit manufactur...

Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.

FDAApr 15, 2005CA, FL, IL +3 more• Spinal Specialties, Inc

Nichols Institute Diagnostics: Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH As...

Controls were out of specification range.

FDAApr 14, 2005Nationwide• Nichols Institute Diagnostics

Varian Medical Systems: Flexible Implant tube, blind end, 350 mm, part # GM110037...

A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.

FDAApr 14, 2005CO, CT, IN +4 more• Varian Medical Systems

Diagnostica Stago, Inc.: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Dia...

Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

FDAApr 13, 2005Nationwide• Diagnostica Stago, Inc.

Heartport, Inc. Route: The Heartport EndoClamp aortic catheter is a 10.5 Fr. wir...

Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.

FDAApr 12, 2005IN• Heartport, Inc. Route

Leica Microsystems, Inc.: Leica M520 Surgical Microscope; a surgical microscope wit...

Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.

FDAApr 12, 2005Nationwide• Leica Microsystems, Inc.

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