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Terminated

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.

FDA Recall Z-0600-2016 · Posted 2016-01-06

Recalling FirmKCI USA, INC.
Recall StatusTerminated
Product CodeOMP
Date Initiated2015-11-25
Date Terminated2016-11-17
Product Quantity12,728 units

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.

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

Japan and Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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