Recall Z-0460-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
| Date | Dec 3, 2012 (initiated Nov 21, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process design |
| Action | 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. |
| Quantity | 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 Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA 3M Health Care, Sarns, Feb 22, 1994 |