CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report
ActiV.A.C. Canister (with Gel) recalled by Kci Usa
KCI USA is recalling ActiV.A.C. Canister (with Gel) for ActiV.A.C. Therapy System for the application of. The recall was initiated on 25 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0600-2016
- FDA event ID
- 72753
- Recalling firm
- KCI USA, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2015
- FDA classified
- 6 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 25 Nov 2015 | Recall initiated by company | |
| 6 Jan 2016 | Classified by FDA | +42 days |
| 13 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Japan and Australia
Questions about this recall
Why was it recalled?
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Which lots are affected?
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.
Where was it sold?
Japan and Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from KCI USA
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3M Prevena Plus 125 Therapy Unit and System Kits recalled by Kci Usa | KCI USA | Packaging Defects | Nationwide |
| Device | CLASS II | 3M V.A.C. VIA Negative Pressure Wound Therapy System recalled by Kci Usa | KCI USA | Packaging Defects | Nationwide |
| Device | CLASS II | Activ.A.C Therapy System recalled by Kci Usa | KCI USA | Other | Nationwide |
| Device | CLASS II | Canister (with Gel) for InfoV.A.C recalled by Kci Usa | KCI USA | Sterility | Nationwide |
| Device | CLASS II | CelluTome Epidermal Harvesting System Harvester Sterile EO recalled | KCI USA | Other | Nationwide |
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