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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 October 16, 2008
Date Posted February 06, 2009
Recall Status1 Terminated 3 on August 04, 2009
Recall Number Z-0630-2009
Recall Event ID 50227
510(K)Number K063618  
Product Classification Pediatric Arterial Perfusion Cannulae - Product Code DWF
Product Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567.

The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Information Lots 0501557 and 0512008.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
FDA Determined
Cause 2		 Device Design
Action An Urgent Medical Device Recall letter dated 10/16/08 was sent to consignees advising them of the problem; requesting that they immediately verify whether or not they had unused cannulae with the affected lot numbers; requesting that they isolate any affected product to prevent use; complete the Customer Response Form, indicate on form if it is medically necessary to use product without introducer; fax Customer Response Form to Terumo CVS at the number listed; and Terumo CVS would contact customers to arrange for the return of unused product. The letter stated that credit would be issued for any unused TenderFlow cannulae that were returned. The quantities to be returned should be indicated on the Customer Response Form. Consignees were advised that, if it was medically necessary to use the affected cannulae, they should be used without the introducer and in accordance with instructions for such use.
Quantity in Commerce 289 (160 plus 59 samples to US and 70 international)
Distribution Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.
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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