BEUDAMED
    FDA Recall Terminated

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    Recall: Z-0534-2008 · Initiated August 21, 2007

    Recall

    Recall Number
    Z-0534-2008
    Event Number
    44734
    Firm
    Ambu Incorporated
    FEI Number
    1121788
    Product Code
    BYE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 21, 2007
    Posted
    December 22, 2007
    Terminated
    June 16, 2008
    Address
    6740 Baymeadow Drive, Glen Burnie, MD, 21060-6412

    Description

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    Reason

    Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.

    Action

    Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by "Urgent Device Recall" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.

    Distribution

    Nationwide.

    Quantity

    197 total