Other Medical Devices Recalls

A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Sep 6, 2013 Other Medical Devices Nationwide View Details →

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical

Class I - Dangerous

The tracheal tube can kink during patient use.

Jan 6, 2014 Other Medical Devices Nationwide View Details →

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical

Class I - Dangerous

The tracheal tube can kink during patient use.

Jan 6, 2014 Other Medical Devices Nationwide View Details →

Trabecular Metal" Reverse Shoulder System

Zimmer

Class I - Dangerous

As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.

Oct 17, 2013 Other Medical Devices Nationwide View Details →

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Winco Mfg.

Class I - Dangerous

A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Sep 6, 2013 Other Medical Devices Nationwide View Details →

GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.

GE Healthcare

Class I - Dangerous

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Oct 1, 2013 Other Medical Devices Nationwide View Details →

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical

Class I - Dangerous

The tracheal tube can kink during patient use.

Jan 6, 2014 Other Medical Devices Nationwide View Details →

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical

Class I - Dangerous

The tracheal tube can kink during patient use.

Jan 6, 2014 Other Medical Devices Nationwide View Details →

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

Teleflex Medical

Class I - Dangerous

The tracheal tube can kink during patient use.

Jan 6, 2014 Other Medical Devices Nationwide View Details →

Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.

Fresenius Medical Care Holdings

Class I - Dangerous

Dialysate Port Leak During Priming of the Dialyzers

Feb 4, 2014 Other Medical Devices Nationwide View Details →

DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

Winco Mfg.

Class I - Dangerous

A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Sep 6, 2013 Other Medical Devices Nationwide View Details →