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Showing 22121–22140 of 22623 results

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Heartport Inc Route: EndoReturn arterial cannula. The EndoReturn arterial can...

Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

FDAOct 2, 2003CA, FL, GA +17 more• Heartport Inc Route

Heartport Inc Route: SoftClamp II arterial cannula is intended to deliver oxyg...

Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

FDAOct 2, 2003CA, FL, GA +17 more• Heartport Inc Route

Merit Medical Systems, Inc: Monarch Inflation Device and Fluid Dispensing Syringe - L...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Manifold Custom Kit. Label reads in part: ''CUSTOM KIT....

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: IntelliSystem25 Inflation Device and Fluid Dispensing Syr...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Inflation Kit. Label reads in part: ''CUSTOM KIT...MERI...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Waste Collection Kit. Label reads in part: ''CUSTOM KIT...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Centerpulse Orthopedics, Inc: RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Scre...

Compalints of acetabular shell disassociating with the bone.

FDASep 30, 2003CA, ID, IN +3 more• Centerpulse Orthopedics, Inc

Abbott Laboratories, Inc: AEROSET System Software version 1.02ER000

Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

FDASep 30, 2003Nationwide• Abbott Laboratories, Inc

Boston Scientific: PeriVac brand Pericardial Fluid Aspiration Procedure Kit ...

The product has the potential to break during withdrawal process.

FDASep 29, 2003CA, CO, IL +11 more• Boston Scientific

Respironics, Inc.: ComfortGel Nasal Mask size medium

product does not contain built in exhalation port

FDASep 29, 2003Nationwide• Respironics, Inc.

Beckman Coulter Inc: Synchron CX4, CX5 and CX9 Pro Systems.

Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

FDASep 29, 2003Nationwide• Beckman Coulter Inc

Biomerieux, Inc.: Coag-A-Mate MTX and MTX II Instrument Operator Manual

Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.

FDASep 29, 2003Nationwide• Biomerieux, Inc.

Respironics, Inc.: ComfortGel Nasal Mask size small

product does not contain built in exhalation port

FDASep 29, 2003Nationwide• Respironics, Inc.

Respironics, Inc.: ComfortGel Nasal Mask size large

product does not contain built in exhalation port

FDASep 29, 2003Nationwide• Respironics, Inc.

Cordis Corporation: This device is labeled as Sterile and is packaged in a Ty...

A packaging defect may compromise the device's sterility barrier.

FDASep 26, 2003Nationwide• Cordis Corporation

Bayer Corp.: Bayer Rapidpoint 405 Blood Gas Analyzer

Potential for bias shift in pO2 values due to air bubble in sample path

FDASep 26, 2003Nationwide• Bayer Corp.

Cordis Corporation: The device is in a tyvek pouch and is labeled in part: A...

A packaging defect may compromise the device's sterility barrier.

FDASep 26, 2003Nationwide• Cordis Corporation

Misys Healthcare Systems: Calculator/ Data Processing Module for Clinical Use.

Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.

FDASep 25, 2003Nationwide• Misys Healthcare Systems

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