| Class 2 Device Recall SARNS HIGHFLOW AORTIC ARCH CANNULA | |
Date Initiated by Firm | May 09, 2012 |
Date Posted | June 20, 2012 |
Recall Status1 |
Terminated 3 on July 11, 2013 |
Recall Number | Z-1833-2012 |
Recall Event ID |
61742 |
510(K)Number | K770429 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG.
The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. |
Code Information |
Catalog number: 12325 and Lot codes: 0551680, 0553010, 0557571, 0559882, 0562967, 0566831, 0569995, 0575870, 0579316, 0584969, 0589928, 0593454, 0595251, 0601331, 0606816, 0611597, 0617494, 0622167, 0626795, 0629156, 0632515, 0636330, 0640190, 0643858, 0649159, 0652241, 0656575, 0663510, and 621463C. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | Tracy Bellanca 734-741-6173 |
Manufacturer Reason for Recall | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors.
Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall. |
Quantity in Commerce | 133,793 (each) |
Distribution | Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DWF
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