Events

Recall of Device Recall Terumo Custom Cardiovascular Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74856
  • Event Risk Class
    Class 2
  • Event Number
    Z-2706-2016
  • Event Initiated Date
    2016-07-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148609
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cardiovascular procedure kit - Product Code OEZ
  • Reason
    Terumo custom cardiovascular procedure kits are labeled as xcoating surface coated tubing, but tubing is non-coated.
  • Action
    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.

Device

Device Recall Terumo Custom Cardiovascular Kits
  • Model / Serial
    US Lot Codes: UG06  UE18R  UF31  UF31A  UF31T    UG13  UG13A  UG20  UG20T  UG27  UG27T   OUS Lot Codes:  UG13  UG13T  UG20  UG20T
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Latin America
  • Product Description
    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-
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA