FDAFebruary 4, 2016device

Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

What to do

FDA enforcement status: Terminated

Brands named

medtronic perfusion systemsmedtronicmedtronic perfusion

UPCs

006431696244360064316962484900643169620155006431696512582064316940966200643169399280006431694781830064316951559800643169475311206431694606942064316963671600643169510203

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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