KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks
KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
KCI USA, INC. is recalling 12,728 units of ActiV.A.C. 300ml Canisters (with Gel) for the ActiV.A.C. Therapy System. These medical devices are used for negative pressure wound therapy in acute, extended, and home care settings. The affected units are Models M8275058-JP/5 and M8275059/5, manufactured between October 5, 2014, and May 29, 2015, and labeled with a 23-month shelf life.
The recall was initiated because there is a potential for small holes, the size of a pin, to develop in the pouches of the canisters. This defect could compromise the integrity of the negative pressure therapy system. The affected products were distributed in Japan and Australia.
Patients and healthcare providers using these specific canister models should contact KCI USA for further instructions on how to manage the recall and replace the affected units.
The recalled product
- 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 connecte
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 12,728
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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.
Distribution
Distribution scope not specified by the agency.
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