Recall Z-0038-05 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Kinetic Concepts, Inc
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
| Date | Oct 22, 2004 (initiated Sep 21, 2004) |
| Status | Terminated |
| Reason | The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised. |
| Root cause | Other |
| Action | The firm initiated the recall by letter and phone calls on September 21, 2004. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS Kinetic Concepts, Inc., Oct 10, 2003 |