Recall Z-0379-06 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Kinetic Concepts, Inc
V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
| Date | Jan 11, 2006 (initiated Sep 16, 2005) |
| Status | Terminated |
| Reason | Possible mislabeling of shipping cartons. |
| Root cause | Other |
| Action | All hospitals and nursing homes contacted via letter and by phone. |
| Quantity | 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. |
| 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 |