ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute ex
FDA device recall Z-0600-2016 · posted 2016-01-06 · Terminated
Recall details
- Recalling firm
- KCI USA, INC.
- 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.
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 12,728 units
- Distribution
- Japan and Australia
- Date initiated
- 2015-11-25
- Date posted
- 2016-01-06
- Date terminated
- 2016-11-17
- Location
- San Antonio, TX
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