FDA Device recall Z-0070-2015
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection
- FDA Device
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection by Kci Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0070-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-18 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kci Usa |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | Lot Number 50775911 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.