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.
Reported: October 22, 2014 Initiated: September 18, 2014 #Z-0070-2015
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.
Details
- Recalling Firm
- KCI USA, Inc.
- Units 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.
- Location
- San Antonio, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by KCI USA, Inc.. Units affected: 1090 pouches (109 boxes).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0070-2015.
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