Recall record at a glance
| Official record | Z-0070-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | KCI USA, Inc. |
| Report date | Oct 22, 2014 |
| Recall initiation date | Sep 18, 2014 |
| Quantity | 1090 pouches (109 boxes) |
| Location | San Antonio, TX, United States |
Official 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.
Why the product was 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.
Distribution information
The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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