BEUDAMED
    FDA Enforcement Class II Terminated

    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    Recall: Z-1722-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1722-2016
    Event ID
    73734
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Surgical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    March 31, 2016
    Classification Date
    May 26, 2016
    Termination Date
    October 21, 2016
    Address
    45 Congress St, N/A, Salem, MA, 01970-5579, United States

    Description

    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    Reason

    Product packaging defective compromising sterility

    Code Info

    Lot number: 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    689 boxes