Negative Pressure Wound Therapy Powered Suction Pump

3M V.A.C. VIA Negative Pressure Wound Therapy System

Due to increase in complaints related to leak alarms

V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01

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

RENASYS EDGE

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

RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing.

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

RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing

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

Invia Motion Negative Pressure Wound Therapy System. Labeled as:

Device may display a battery missing error.

ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The softw

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

V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STE

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/ RENASYS EZ Plus 250 mL canister with Solidifier

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

RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier

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