Recall Z-2161-2010 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02
| 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 | 10 packs |
| Distribution | Distribution USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K823451 | CLEAR CARDIOPLEJIA DELIVERY SYSTEM 3M Health Care, Sarns, Jan 14, 1983 |