Home / Recalls / KCI USA, Inc. / Z-0070-2015

Z-0070-2015 Class II Terminated

Recalled by KCI USA, Inc. — San Antonio, TX

Recall Details

Product Type
Devices
Report Date
October 22, 2014
Initiation Date
September 18, 2014
Termination Date
July 24, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1090 pouches (109 boxes)

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.

Distribution Pattern

The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.

Code Information

Lot Number 50775911

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