Events

Recall of Device Recall Overpressure Safety Valve

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

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
    78546
  • Event Risk Class
    Class 2
  • Event Number
    Z-0256-2018
  • Event Initiated Date
    2017-06-27
  • 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=159745
  • 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
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - Product Code DTL
  • Reason
    Terumo cardiovascular systems (terumo cvs) has received reports of no flow through the over-pressure safety (ops) valve.
  • Action
    The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it. Beginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows: CUSTOMER INSTRUCTIONS Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form . Terumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday- Friday, 8 a.m . - 6 p.m. ET Terumo Safety Alert Fax: 1.410.392.7183 Terumo Safety Alert Email: TCVSCustomerResponseElkton@terumomedical.com

Device

Device Recall Overpressure Safety Valve
  • Model / Serial
    SAFETY ALERT Lot Codes:  (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10    (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01   LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
  • Product Description
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA