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U.S. Department of Health and Human Services

Class 2 Device Recall V.A.C.

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  Class 2 Device Recall V.A.C. see related information
Date Initiated by Firm September 21, 2004
Date Posted October 22, 2004
Recall Status1 Terminated 3 on June 07, 2005
Recall Number Z-0038-05
Recall Event ID 30212
510(K)Number K032310  
Product Classification Apparatus, Suction, Ward Use, Portable, Ac-Powered - Product Code JCX
Product V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Code Information Part M6275043-5: 01.27.04.21v; 01.27.04.22v; 01.27.04.23v; 02.23.04.03; 05.06.04.07; 05.17.04.01; 05.20.04.08; 06.23.04.12; 07.07.04.13; and 08.11.04.04  Part M6275065-5: 11.06.03.01V; 11.06.03.02V; 11.06.03.03V; 11.21.03.15; 12.01.03.25; 12.15.03.14; 12.18.03.07; 01.16.04.09; 01.08.04.10; 01.20.04.10; 12.15.03.14; 02.04.04.23; 01.21.04.24; 02.09.04.22; 02.23.04.07; 03.30.04.13; 03.22.04.10; 05.04.04.08; 05.14.04.04; 05.26.04.09; 06.02.04.07; 06.04.04.15; 06.17.04.12; 07.07.04.11; 07.07.04.12; 07.20.04.14; 07.30.04.03; and 08.03.04.06
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		 The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall by letter and phone calls on September 21, 2004.
Quantity in Commerce 29610 units
Distribution The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
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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