Z-0600-2016Class II

ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in...

Name: Z-0600-2016 ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in...
Creator: Kci USA, Inc.
Published: 2015-11-25
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2015-11-25 / Terminated / root cause: packaging

FDA source

KCI USA, INC. began a recall of ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The... on 2015-11-25. FDA classified it as Class II and gives the reason as "There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0600-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-01-06
Terminated: 2016-11-17
Recalling firm: KCI USA, Inc.
Product: ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Customer notification letters were sent out the week of November, 23, 2015. The international distributors will be responsible for notification to their sub-consignees.
Quantity in commerce: 12,728 units
Distribution: Japan and Australia
Product codes and lots: Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0600-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0600-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

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)