V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Prod
FDA device recall Z-0379-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Kinetic Concepts, Inc
- Reason for recall
- Possible mislabeling of shipping cartons.
- Action taken
- All hospitals and nursing homes contacted via letter and by phone.
- Root cause
- Other
- Status
- Terminated
- Product code
- JCX
- Quantity affected
- 64 cartons.
- Distribution
- Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.
- Date initiated
- 2005-09-16
- Date posted
- 2006-01-11
- Date terminated
- 2006-02-21
- 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 |