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Showing 21661–21680 of 22584 results

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Becton Dickinson Infusion Therapy: BD L-Cath EX (20ga x 15cm), L-Cath Catheter System

Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

FDAMar 9, 2004Nationwide• Becton Dickinson Infusion Therapy

Becton Dickinson Infusion Therapy: BD L-Cath NN (24ga x 30cm), L-Cath Catheter System

Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

FDAMar 9, 2004Nationwide• Becton Dickinson Infusion Therapy

Spinal Concepts, Inc: Ant-Cer Dynamic Cervical Plating System Literature. Devi...

Recall of product literature that describes use of the device.

FDAMar 8, 2004AZ, CA, CO +24 more• Spinal Concepts, Inc

Philips Medical Systems (Cleveland) Inc: Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.

The CT couch may move downward to its lower limit without command.

FDAMar 8, 2004Nationwide• Philips Medical Systems (Cleveland) Inc

Hill-Rom, Inc.: Hill Rom brand Advanta bed; model P1600.

A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed.

FDAMar 8, 2004CA, DE, ID +8 more• Hill-Rom, Inc.

Philips Medical Systems (Cleveland) Inc: Philips Brilliance CT Scanner System, 6, 10 & 16 slice im...

The CT couch may move downward to its lower limit without command.

FDAMar 8, 2004Nationwide• Philips Medical Systems (Cleveland) Inc

Boston Scientific Corporation: PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen ,...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains...

Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150 front end, ...

If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

FDAMar 5, 2004Nationwide• Roche Diagnostics Corp.

Hill-Rom Manufacturing, Inc.: Magnum II Bariatric Patient Care System

Bed may pose a health hazard due to: A) Inability to articulate the frame during transport, B) Exposed sharp edge of footplate, C) Shear point between seat section and lymph panel and D) Patient fall.

FDAMar 4, 2004Nationwide• Hill-Rom Manufacturing, Inc.

Instrumentation Laboratory Co.: ACL Advance Instrument Analyzer

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

Gish Biomedical Inc: Vision Hollow Fiber Oxygenator with GBS Coating

Customers reported leakage.

FDAMar 4, 2004AR, CA, CT +10 more• Gish Biomedical Inc

Instrumentation Laboratory Co.: ACL Futura Instrument Analyzer

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

Surgical Specialties Puerto Rico, Inc. Road: Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up,...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Surgical Specialties Puerto Rico, Inc. Road: Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

ADAC Laboratories: Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Pla...

Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

FDAMar 3, 2004Nationwide• ADAC Laboratories

ADAC Laboratories: Pinnacle3 Radiation Therapy Planning System, Version 7.0e...

A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.

FDAMar 3, 2004Nationwide• ADAC Laboratories

Surgical Specialties Puerto Rico, Inc. Road: Stylus Angled Knife - 52-2835 Clear Corneal Knife, double...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Surgical Specialties Puerto Rico, Inc. Road: Stylus Brand Angled Knives - 52-2912, Slit Knife, paralle...

Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.

FDAMar 3, 2004Nationwide• Surgical Specialties Puerto Rico, Inc. Road

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