Drug recall
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection…
FDA recall event 69368 · Class II · KCI USA, Inc.
Key facts
| Event ID | 69368 |
|---|---|
| Recall numbers | Z-0070-2015 |
| Recalling firm | KCI USA, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 18, 2014 |
| Report date | Oct 22, 2014 |
| Termination date | Jul 24, 2015 |
| City | San Antonio |
| State | TX |
| Country | United States |
| FEI number | 3005178245 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: