KCI Recalls V.A.C. GranuFoam Silver Dressing Due to Expiry Date Error
KCI USA, Inc. is recalling V.A.C. GranuFoam Silver Dressing because some sterile pouches display an incorrect expiry date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error (incorrect expiry date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
KCI USA, Inc. is recalling a portion of the V.A.C. GranuFoam Silver Dressing, reference number M8275099/10, lot 50775977. The recall involves 1,090 pouches (109 boxes) that were incorrectly manufactured with an incorrect expiry date on the sterile pouch.
The correct expiry date of 2015-11 is printed on the case label, but the individual pouch label incorrectly identifies the expiry date as 2016-11. This labeling discrepancy may lead to the use of expired sterile medical devices.
The affected product was distributed to Mexico, Turkey, and the United Arab Emirates only. The affected product was not distributed to the United States. Consumers and healthcare providers in these regions should check their inventory for this specific lot and reference number and stop using the affected products.
The recalled product
- 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.
- Manufacturer
- KCI USA, Inc.
- Category
- Medical Device — Wound Care
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 50775911
Distribution
Distribution scope not specified by the agency.
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