—#148609

Product

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-

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: US Lot Codes: UG06 UE18R UF31 UF31A UF31T UG13 UG13A UG20 UG20T UG27 UG27T OUS Lot Codes: UG13 UG13T UG20 UG20T

Why it was recalled

Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated

Root cause (FDA determination)

Process control

Action the firm took

Terumo Cardiovascular Systems issued the Safety Alert dated July 25, 2016 and advises the user that their kit may include uncoated tubing, and further advises the consignee to continue using their kits with consideration of anticoagulation protocols during a procedure. Each consignee is asked to complete a Customer Response Form, and to return the Customer Response Form to Terumo acknowledging their receipt of the form. Consignees can return their affected product for credit/replacement; however, return of the product from the field is a customer option and is not under recommendation from Terumo Cardiovascular Systems. For further questions, please call (800) 262-3304.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Nationwide Foreign: Canada, Latin America

Timeline

Recall initiated: 2016-07-25
Terminated: 2019-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148609. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.