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 software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
This recall has been terminated (originally issued January 6, 2016).
- Company
- Kci Usa, Inc.
- Recall Initiated
- November 25, 2015
- Posted
- January 6, 2016
- Terminated
- November 17, 2016
- Recall Number
- Z-0600-2016
- Quantity
- 12,728 units
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
Reason for Recall
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Distribution
Japan and Australia
Lot / Code Info
Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.
Root Cause
Package design/selection
Action Taken
Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees.
More recalls by Kci Usa, Inc.
3M V.A.C. VIA Negative Pressure Wound Therapy System
REF:
VIAKIT077D01/US - V.A.C. VIA 7 Day Kit
VIA...
Feb 14, 2025
3M Prevena Plus 125 Therapy Unit and System Kits
REF:
PRE3021US Prevena Plus Duo Peel and Place 20cm...
Feb 14, 2025
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01
The 3M" V.A.C. Ulta Negative Pressure Wound The...
Nov 22, 2024