Recall Z-1037-03 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Quest Medical, Inc
Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
| Date | Jul 22, 2003 (initiated May 23, 2003) |
| Status | Terminated |
| Reason | Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery. |
| Root cause | Other |
| Action | The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003. |
| Quantity | 2158 devices |
| Distribution | CA, PA, FL, ME, TX, MA, OH, ON, NM, WA, MO, GA, SC, MS, IL, LA, NC, NJ, MA, AK, TN, MT, WI, IN, WV, NE, Japan, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953838 | MYOCARDIAL PROTECTION SYSTEM Quest Medical, Inc., Mar 6, 1996 |