Recall Z-0543-2011 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Edwards Lifesciences Llc
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
| Date | Dec 7, 2010 (initiated Oct 19, 2010) |
| Status | Terminated |
| Reason | Monitoring and Infusion Set connectors may break during manipulation. |
| Root cause | Employee error |
| Action | Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278. |
| Quantity | 570 sets |
| Distribution | Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892377 | RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET Research Medical, Inc., Dec 7, 1989 |