Terumo Cardiovascular Systems (CVS) Monday notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes, after it received five reports of difficulty retracting the introducer from the cannula.
The company said that there have been no reports of patient injury or death associated with the product. However, 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, Terumo explained in its recall notice.
Terumo CVS said it distributed the product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommends that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.
The Ann Arbor, Mich.-based Terumo informed the FDA of the recall.
The Tenderflow Pediatric Arterial Cannula catalog and lot numbers affected are:
|Catalog Number||Lot Number|
|813569||0502199, 0513068, 0517852|
|813571||0507120, 0512919, 0518680|