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Terumo Cardiovascular Systems Corp recalls Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the di
Recalled November 12, 2014 · FDA recall Z-0159-2015 · 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
Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 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 Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
Manufacturer(s)
Terumo Cardiovascular Systems Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →