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Recall of Tenderflow Pediatric Arterial Cannulae

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Defective Tenderflow Pediatric Arterial Cannulae are being recalled by Terumo Cardiovascular Systems.  An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

According to the recall notice, when the  introducer  cannot be retracted from the Tenderflow Pediatric Arterial Cannulae, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.  According to the Food & Drug Administration (FDA), the recall was issued after Terumo received five reports of difficulty retracting the introducer from the cannula. There there have been no reports of patient injury or death associated with the defective Tenderflow Pediatric Arterial Cannulae.

Terumo said the recalled Pediatric Arterial Cannulae  were directly distributed to 68 U.S. hospitals, and all of the hospitals were notified of the voluntary recall in a letter dated Oct. 16, 2008. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.

The Tenderflow Pediatric Arterial Cannulae recall involves the following catalog and lot numbers:

Catalog Number    Lot Number
Catalog #813568    Lot #s 0501639, 0512002
Catalog #813567    Lot #s 0501557, 0512008
Catalog #813570    Lot #s 0502200, 0513069
Catalog #813569    Lot #s 0502199, 0513068, 0517852
Catalog #813572     Lot #s 0507121, 0512918
Catalog #813571    Lot #s 0507120, 0512919, 0518680
Catalog #813574    Lot #s 0509240
Catalog #813573    Lot #s 0509238, 0517874
Catalog #813576    Lot #s 0509241
Catalog #813575    Lot #s 0500759, 0513331
Catalog #813578    Lot #s 0500760
Catalog #813577    Lot #s 0502878

For more information clinicians within the U.S.  may contact  Terumo at 800-521-2818, Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.

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