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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns" SoftFlow Aortic Cannula without Suture Flange

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  Class 2 Device Recall Sarns" SoftFlow Aortic Cannula without Suture Flange see related information
Date Initiated by Firm October 23, 2013
Date Posting Updated November 08, 2013
Recall Status1 Terminated 3 on July 18, 2014
Recall Number Z-0194-2014
Recall Event ID 66624
510(K)Number K934127  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long.

Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Code Information Catalog Number 5798, Lot Numbers 0677301
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow¿ Aortic Cannulae and Sarns" Venous Return Cannulae.
FDA Determined
Cause 2
Employee error
Action On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818.
Quantity in Commerce 70 units
Distribution Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
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
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