Recalls for Negative Pressure Wound Therapy Powered Suction Pump

Due to increase in complaints related to leak alarms

Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Device may display a battery missing error.

There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Modification of the bacterial overflow guard (filter) and related changes to product labeling.

Modification of the bacterial overflow guard (filter) and related changes to product labeling.

Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.

On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.

Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin

Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.

Power cords may crack and fail inside plug with potential for fire hazard.

Power cords may crack and fail inside plug with potential for fire hazard.

Power cords may crack and fail inside plug with potential for fire hazard.

Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.

Labeling: The expiration date does not appear on the product label.

Labeling: The expiration date does not appear on the product label.

Labeling: The expiration date does not appear on the product label.

Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

Lack of 510k clearance for design modification.

Lack of 510k clearance for design modification.

Potential sterile barrier breach

The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

Sterility seal integrity failures on the Renasys Sterile Transparent Film