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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo TenderFlow Pediatric Arterial Cannulae

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 Class 2 Recall
Terumo TenderFlow Pediatric Arterial Cannulae
see related information
Date Posted July 10, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0877-2007
Recall Event ID 37996
Premarket Notification
510(K) Number
K063618 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.
Code Information Lot 2120265.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
Quantity in Commerce 100
Distribution Nationwide.
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 = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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