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
- Company
- Kinetic Concepts, Inc
- Recall Initiated
- September 21, 2004
- Posted
- October 22, 2004
- Terminated
- June 7, 2005
- Recall Number
- Z-0038-05
- Quantity
- 29610 units
- Firm Location
- San Antonio, TX
Reason for Recall
The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
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.
Lot / Code Info
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
Root Cause
Other
Action Taken
The firm initiated the recall by letter and phone calls on September 21, 2004.