Recall Z-0070-2015 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, Inc.
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 STERILE Single Use only Latex Free Rx Only.
| Date | Oct 15, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units. |
| Quantity | 1090 pouches (109 boxes) |
| Distribution | The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.