BEUDAMED
    FDA Enforcement Class III Terminated

    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

    Recall: Z-1713-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1713-2020
    Event ID
    85139
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    February 28, 2020
    Classification Date
    April 15, 2020
    Termination Date
    August 11, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

    Reason

    Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.

    Code Info

    Lot number 250887

    Distribution

    International distribution to Japan only.