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.
FDA device recall Z-0038-05 · posted 2004-10-22 · Terminated
Recall details
- Recalling firm
- Kinetic Concepts, Inc
- Reason for recall
- The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
- Action taken
- The firm initiated the recall by letter and phone calls on September 21, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- JCX
- Quantity affected
- 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,
- Date initiated
- 2004-09-21
- Date posted
- 2004-10-22
- Date terminated
- 2005-06-07
- Location
- San Antonio, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (K032310) | Kinetic Concepts, Inc. | 2003-10-10 |