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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 Device Recall Terumo TenderFlow Pediatric Arterial Cannulae see related information
Date Initiated by Firm May 22, 2007
Date Posted July 10, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0883-2007
Recall Event ID 37996
510(K)Number K063618  
Product Classification Arterial Cannulae - Product Code DWF
Product Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576.
Code Information Lot 2120271.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
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		 Other
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 30
Distribution Nationwide.
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 = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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