Recall Z-0600-2016 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, INC.
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
| Date | Jan 6, 2016 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters. |
| Root cause | Package design/selection |
| Action | Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees. |
| Quantity | 12,728 units |
| Distribution | Japan and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.