Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expirat
FDA device recall Z-0178-2015 · posted 2014-11-06 · Terminated
Recall details
- Recalling firm
- Dokitz NovoSci
- Reason for recall
- The single leg of the PAY connector has been observed to become detached.
- Action taken
- The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 240 units
- Distribution
- MO, TX, PA, IL, MD, UT
- Date initiated
- 2014-09-18
- Date posted
- 2014-11-06
- Date terminated
- 2015-05-15
- Location
- Conroe, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE PARALLEL Y CONNECTORS (K801404) | Texas Medical Products, Inc. | 1980-06-30 |