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Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Us
Recalled November 12, 2014 · FDA recall Z-0156-2015 · 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
596 units; 876 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 Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
Manufacturer(s)
Terumo Cardiovascular Systems Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →