FDA Device

Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R

Hazard

An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

What You Should Do

Remedy

A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm.

Products

Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
Brand
Medtronic Perfusion Systems
UPC
Lot 0402000017

Units Affected

132 units