Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) lo
FDA device recall Z-0883-2007 · posted 2007-07-10 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
- Action taken
- Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 30
- Distribution
- Nationwide.
- Date initiated
- 2007-05-22
- Date posted
- 2007-07-10
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TENDERFLOW PERIATRIC ARTERIAL CANNULA (K063618) | Terumo Cardiovascular Systems Corp. | 2007-03-13 |