Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 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 distribut

U.S. FDA — Device Enforcement · United States · 2015-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0600-2016
Date of alert: 2015-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: KCI USA, INC.
Product category: device
Product type: Devices

Reported risk: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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