BEUDAMED
    FDA Recall Terminated

    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

    Recall: Z-2632-2017 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2632-2017
    Event Number
    77399
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    KZD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 22, 2017
    Terminated
    June 14, 2018
    Address
    2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

    Description

    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

    Reason

    It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.

    Action

    The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email [email protected] if you have any questions.

    Distribution

    U.S. Distribution: TX only

    Quantity

    1 unit