Recall Z-2440-2008 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
KCI USA, Inc.
500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.
| Date | Sep 20, 2008 (initiated Jul 29, 2008) |
| Status | Terminated |
| Reason | The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic. |
| Root cause | Equipment maintenance |
| Action | Urgent - Medical Device Recall letters were sent within the US on 07/29/08 via UPS next day delivery service and a return receipt was maintained to demonstrate delivery of the recall to all consignees. Additionally, firm is sending representatives into accounts which received more than three sales units of canisters and to all foreign consignee locations to facilitate quarantine and replacement of affected stock. Consignees asked to confirm that adequate flow is being delivered and that the dressing is being drawn down for those patients currently using the InfoV.A.C. Canisters. Also, consi |
| Quantity | 79,275 canisters. |
| Distribution | Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063740 | V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 Kci USA, Inc., Jun 7, 2007 |