Z-0070-2015Class II

V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection...

Name: Z-0070-2015 V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection...
Creator: KCI USA, Inc.
Published: 2014-09-18
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2014-09-18 / Terminated / root cause: labeling and UDI

FDA source

KCI USA, Inc. began a recall of 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... on 2014-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0070-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-10-15
Terminated: 2015-07-24
Recalling firm: KCI USA, Inc.
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.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.
Quantity in commerce: 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.
Product codes and lots: Lot Number 50775911

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-15

Product code OMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)