Sharon Ryan
(734) 741- 6104
FOR IMMEDIATE RELEASE --Ann Arbor, Mich. -- December 1, 2008 --- Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.
There have been no reports of patient injury or death associated with the product.
Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected:
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