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U.S. Department of Health and Human Services

Class 1 Device Recall Terumo Coronary Ostia Cannulae

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 Class 1 Recall
Terumo Coronary Ostia Cannulae
see related information
Date Posted June 14, 2011
Recall Status1 Terminated on March 21, 2012
Recall Number Z-2555-2011
Recall Event ID 58762
Premarket Notification
510(K) Number
K822210 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product 804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment
Code Information Part Number 804117 Lot 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedu
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.
Quantity in Commerce 4540
Distribution Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
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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