BEUDAMED
    FDA Enforcement Class II Terminated

    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    Recall: Z-0920-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0920-2020
    Event ID
    84497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    December 9, 2019
    Classification Date
    January 30, 2020
    Termination Date
    September 17, 2020
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    Reason

    The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

    Code Info

    Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011

    Distribution

    The products were distributed to the following US states: MI and TX.

    Quantity

    7