V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring Sens
FDA device recall Z-0070-2015 · posted 2014-10-15 · Terminated
Recall details
- Recalling firm
- KCI USA, Inc.
- Reason for recall
- 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.
- Action taken
- KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 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.
- Date initiated
- 2014-09-18
- Date posted
- 2014-10-15
- Date terminated
- 2015-07-24
- Location
- San Antonio, TX
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