BEUDAMED
    FDA Enforcement Class II Terminated

    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

    Recall: Z-0256-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0256-2018
    Event ID
    78546
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2017
    Initiation Date
    June 27, 2017
    Classification Date
    December 18, 2017
    Termination Date
    July 16, 2019
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315, United States

    Description

    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

    Code Info

    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

    Distribution

    Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

    Quantity

    297,222 units