18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during
FDA device recall Z-0459-2013 · posted 2012-12-03 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl
- Action taken
- TERUMO sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to remove this cannulae from circulation and return them for credit. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 5760 total
- Distribution
- Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to
- Date initiated
- 2012-11-21
- Date posted
- 2012-12-03
- Date terminated
- 2013-04-23
- 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 |