Recall Z-0178-2015 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Dokitz NovoSci
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
| Date | Nov 6, 2014 (initiated Sep 18, 2014) |
| Status | Terminated |
| Reason | The single leg of the PAY connector has been observed to become detached. |
| Root cause | Process control |
| Action | The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci. |
| Quantity | 240 units |
| Distribution | MO, TX, PA, IL, MD, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801404 | DISPOSABLE PARALLEL Y CONNECTORS Texas Medical Products, Inc., Jun 30, 1980 |