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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns SoftFlow Aortic Cannula

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 Class 2 Recall
Sarns SoftFlow Aortic Cannula
see related information
Date Posted March 23, 2012
Recall Status1 Terminated on April 03, 2013
Recall Number Z-1295-2012
Recall Event ID 60718
Premarket Notification
510(K) Numbers
K083301  K934127 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Sarns"Soft-Flow® Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
Code Information catalog number: 5768 and lot numbers: 0543663, 0545336, 0548173, 0551627, 0554939, 0557537, 0561015, 0562328, 0566132, 0570465, 0575369, 0579077, 0582604, 0589450, 0593473, 0599339,0603200, 0605098, 0609907, 0612593, 0618435, 0619848, 0621468, 0625580, 0630484, 0632631, 0634752, 0637801, 0641064, 0645874, 593736C, and 621484C.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
For Additional Information Contact Tracy Bellanca
734-741-6173
Manufacturer Reason
for Recall
During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
FDA Determined
Cause 2
DESIGN: Process Design
Action Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumomedical.com and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 188,282 Cannulae and 248 Custom Tubing Packs
Distribution USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
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
510(K)s with Product Code = DWF and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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