Device product
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.
Z-0070-2015
Product summary
- Firm
- KCI USA, Inc.
- Event
- Event 69368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1090 pouches (109 boxes)
- Official record key
device-enforcement:Z-0070-2015
Official wording
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.
Code information: Lot Number 50775911
Distribution pattern: The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
Derived failure modes
-
Unknown
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.