Recall Z-0361-2016 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quest Medical, Inc.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
| Date | Dec 2, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | The products have been found to intermittently exhibit a seal failure during use. |
| Root cause | Equipment maintenance |
| Action | The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15. |
| Quantity | 18,761 units |
| Distribution | Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953838 | MYOCARDIAL PROTECTION SYSTEM Quest Medical, Inc., Mar 6, 1996 |