Class 2 Device Recall Sarns SoftFlow Aortic Cannula

• Date Initiated by Firm: February 23, 2012
• Date Posted: March 23, 2012
• Recall Status: Terminated on April 03, 2013
• Recall Number: Z-1295-2012
• Recall Event ID: 60718
• 510(K)Number: K934127 K083301
• 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 MI 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: Nonconforming Material/Component
• 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 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.