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.
This recall has been terminated (originally issued October 15, 2014).
- Company
- Kci Usa, Inc.
- Recall Initiated
- September 18, 2014
- Posted
- October 15, 2014
- Terminated
- July 24, 2015
- Recall Number
- Z-0070-2015
- Quantity
- 1090 pouches (109 boxes)
- Firm Location
- San Antonio, TX
- Official Source
- View on FDA website ↗
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.
Distribution
The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
Lot / Code Info
Lot Number 50775911
Root Cause
Error in labeling
Action Taken
KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.
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