| | Class 2 Recall
Sarns Soft Flow Aortic Cannulae |  |
| Date Posted |
December 03, 2012 |
| Recall Number |
Z-0460-2013 |
| Product |
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. |
| Code Information |
catalog number: 7072 and lot number: 0602542, 0614871, and 0620810.
|
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586 |
| Consumer Instructions |
Contact the recalling firm for information |
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 |
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 in Commerce |
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. |
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