BEUDAMED
    FDA Recall Terminated

    ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case

    Recall: Z-1845-2008 · Initiated May 12, 2008

    Recall

    Recall Number
    Z-1845-2008
    Event Number
    48124
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    GBS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 12, 2008
    Posted
    August 14, 2008
    Terminated
    August 20, 2009
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case

    Reason

    Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate

    Action

    Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.

    Distribution

    Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.

    Quantity

    5 cases (10 individual/case)