Device Recall Terumo Custom Cardiovascular Kits

US Lot Codes: UG06  UE18R  UF31  UF31A  UF31T    UG13  UG13A  UG20  UG20T  UG27  UG27T   OUS Lot Codes:  UG13  UG13T  UG20  UG20T

Cardiovascular Devices

2

No

Nationwide Foreign: Canada, Latin America

Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: || This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. || US Product Codes: || 72021 || 72358 || 71180-01 || 76021 || 76022 || 76023 || 76024 || 76025 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 74163-03 || 71296-01 || 74460-01 || 74460-01 || 74460-01 || 73208-03 || 74382-01 || 74382-01 || 74382-01 || 74916 || 74916 || 74916 || 70089-07 || 74063-01 || 74063-01 || 74460-01 || 74460-01 || 74460-01 || 74460-01 || 75252-01 || 74951 || 75881 || 74271-01 || 71085-02 || 72742 || 75314 || 75368 || 75368 || 76095 || 76095 || 73339-01 || 73789 || 74417 || 72204 || 72965-03 || 73644 || 73645-01 || 73700 || 73861 || 73871 || 73901-03 || 75612 || 75617 || 75986 || 76095 || 73645-01 || 73645-01 || 70099-04 || 75544 || 75272 || 75674 || 75674 || 73180 || 73180 || 73180 || 75437 || 75674 || 75274 || 73811 || 73811 || 74915 || 71175-03 || 73738 || 76117 || 75129 || 75642 || 75642 || 72596 || 72596 || 72596 || 75179 || 74980-01 || 8340TXC-07 || 8340TXC-07 || 8340TXC-07 || 71875-01 || 74235-01 || 74476 || 75059 || 75547 || 75547 || 74235-01 || 8351TXC-01 || 73124 || 73281-01 || 73282-01 || 73874 || 74477 || 8340TXC-07 || 76069 || 76070 || 76071 || 76072 || 74737 || 73933 || 73933 || 73933 || 73933 || 73933 || 73933 || 71608-04 || 75413 || 74959 || 75472 || 75472 || 75449 || 75923 || 75923 || 73729-01 || 73730-01 || 74046-