Recall Z-0070-2015— KCI USA, Inc.
Class II · Terminated
Class II FDA medical device recall by KCI USA, Inc., initiated 2014-09-18, terminated 2015-07-24. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- KCI USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-18
- Terminated
- 2015-07-24
- Firm location
- San Antonio, TX, United States
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.