BEUDAMED
    FDA Recall Terminated

    6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

    Recall: Z-1980-2017 · Initiated October 6, 2016

    Recall

    Recall Number
    Z-1980-2017
    Event Number
    76059
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    BWN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 6, 2016
    Terminated
    July 26, 2019
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

    Reason

    Supplied Directions for Use (DFU) did not contain a recommended service interval.

    Action

    Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to [email protected]. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.

    Distribution

    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

    Quantity

    297