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U.S. Department of Health and Human Services

Class 2 Device Recall V.A.C. Abdominal Dressing System

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  Class 2 Device Recall V.A.C. Abdominal Dressing System see related information
Date Initiated by Firm March 17, 2006
Date Posted May 23, 2006
Recall Status1 Terminated 3 on November 22, 2006
Recall Number Z-0873-06
Recall Event ID 35089
510(K)Number K022011  
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
Product Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
Code Information Lot Codes: 05.13.05.01; 05.24.05.16; 06.09.05.24; 06.15.05.13; 07.06.05.08; 07.13.05.05.03; 07.14.05.06; 07.19.05.10; 07.28.05.15; 08.03.05.15; 08.10.05.15; 08.17.05.18; 08.17.05.30; 08.17.05.31; 09.07.05.23; 09.21.05.16; 09.28.05.16; 10.05.05.29; 10.19.05.22; 12.28.05.06; 01.11.06.16; 02.01.06.15; 02.01.06.16; 02.15.06.23; 02.15.06.24.
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
FDA Determined
Cause 2		 Other
Action Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.
Quantity in Commerce 6453 total units.
Distribution Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland.
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 = FTL and Original Applicant = KINETIC CONCEPTS, INC.
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