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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Soft Flow Aortic Cannulae

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 Class 2 Recall
Sarns Soft Flow Aortic Cannulae
see related information
Date Posted December 03, 2012
Recall Status1 Terminated on April 23, 2013
Recall Number Z-0456-2013
Recall Event ID 63407
Premarket Notification
510(K) Number
K934127 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product 24 Fr 8mm Sft Flow Str 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: 5841 and 5845 and lot number: 0581536 and 0581138.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = 3M HEALTH CARE, SARNS
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