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U.S. Department of Health and Human Services

Class 2 Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System

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 Class 2 Device Recall ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy Systemsee related information
Date Initiated by FirmNovember 25, 2015
Date PostedJanuary 06, 2016
Recall Status1 Terminated 3 on November 17, 2016
Recall NumberZ-0600-2016
Recall Event ID 72753
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
ProductActiV.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.
Code Information 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.
Recalling Firm/
Manufacturer		 KCI USA, INC.
12930 W Interstate 10
San Antonio TX 78249-2248
For Additional Information ContactSteve Jackson
800-275-4524
Manufacturer 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.
FDA Determined
Cause 2		Package design/selection
ActionCustomer 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 Commerce12,728 units
DistributionJapan and Australia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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