Recall Z-2150-2010 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246
| Date | Aug 2, 2010 (initiated Jun 8, 2010) |
| Status | Terminated |
| Reason | Vent port may be occluded and prevent delivery of fluid |
| Root cause | Equipment maintenance |
| Action | Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately. |
| Quantity | 20 packs |
| Distribution | Distribution USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900640 | MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU 3M Company, Apr 20, 1990 |