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U.S. Department of Health and Human Services

Class 3 Device Recall V.A.C. ATS Wound Healing System

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  Class 3 Device Recall V.A.C. ATS Wound Healing System see related information
Date Initiated by Firm September 16, 2005
Date Posted January 11, 2006
Recall Status1 Terminated 3 on February 21, 2006
Recall Number Z-0379-06
Recall Event ID 34310
510(K)Number K032310  
Product Classification Apparatus, Suction, Ward Use, Portable, Ac-Powered - Product Code JCX
Product V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
Code Information Lot #08150506M
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 Possible mislabeling of shipping cartons.
FDA Determined
Cause 2		 Other
Action All hospitals and nursing homes contacted via letter and by phone.
Quantity in Commerce 64 cartons.
Distribution Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JCX and Original Applicant = KINETIC CONCEPTS, INC.
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