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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns

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 Class 2 Recall
Sarns
see related information
Date Posted June 27, 2012
Recall Status1 Terminated on April 24, 2013
Recall Number Z-1894-2012
Recall Event ID 61731
Premarket Notification
510(K) Number
K873212 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Code Information Catalog number: 80004-03 and lot number: MG14, MK16, MN15, NC07, NE18, NK01, NM31, PA30, and PD05.
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 production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Terumo sent an Urgent Medical Device Recall letter dated May 9, 2012 to All US first consignees will receive a removal notification letter via Federal Express. The letter identified the affected products, reason for correction and actions to be taken. Customers were instructed to discontinue use of affected products and return for replacement. The letter advised customers to assure that all users are aware of this notice and to fill out and return the attached Response Form. For questions call Terumo CVS Customer Service at 1-800-521-2818 or by fax at 1-800-292-6551.
Quantity in Commerce 53,139 (each) in total
Distribution Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
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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