Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long

FDA device recall Z-0631-2009 · posted 2009-02-06 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DWF

Quantity affected

178 (110 plus 58 samples to US and 10 international)

Distribution

Worldwide Distribution --- including USA and countries of Australia, Belgium and Canada.

Date initiated

2008-10-16

Date posted

2009-02-06

Date terminated

2009-08-04

Location

Ann Arbor, MI

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