Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 in
FDA device recall Z-0181-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
- Action taken
- Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 48
- Distribution
- California, Indiana, Missouri, Brazil and Germany.
- Date initiated
- 2005-10-19
- Date posted
- 2005-11-23
- Date terminated
- 2006-03-10
- 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 |
|---|---|---|
| SARNS LOW JETTING AORTIC ARCH CANNULA (K934127) | 3M Health Care, Sarns | 1994-02-22 |