Terumo Cardiovascular Systems Corp recalls Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage:

Recalled November 12, 2014 · FDA recall Z-0157-2015 · Terumo Cardiovascular Systems

Hazard

Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line · FDA Class II

Units

165 units

Sold at

Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Description

Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

Product

Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity

Manufacturer(s)

Terumo Cardiovascular Systems Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →