BEUDAMED
    FDA Recall Terminated

    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

    Recall: Z-2461-2018 · Initiated May 7, 2018

    Recall

    Recall Number
    Z-2461-2018
    Event Number
    80306
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 7, 2018
    Terminated
    June 8, 2020
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

    Reason

    The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

    Action

    On May 24, 2018, the firm distributed Urgent: Medical Device Recall letters to affected U.S. customers. Customers were instructed to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-888-473-8015 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall (removal). 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return all unused D-Special PROLENE Polypropylene Suture & D-Special PRONOVA Poly (Hexafluoropropylene - VDF) Suture products that are in their inventory immediately. Only D-Special PROLENE Polypropylene Suture & D-Special PRONOVA Poly (Hexafluoropropylene - VDF) Suture product subject to this recall (removal) returned by September 21, 2018 will be eligible for credit reimbursement. Any product subject to this recall (removal) returned after September 21, 2018 will not be eligible for credit reimbursement. 7. To return product subject to this recall (removal), photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for

    Distribution

    Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

    Quantity

    4440