BEUDAMED
    FDA Recall Terminated

    ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

    Recall: Z-2889-2016 · Initiated August 1, 2016

    Recall

    Recall Number
    Z-2889-2016
    Event Number
    74901
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    KDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2016
    Terminated
    November 29, 2017
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

    Reason

    ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.

    Action

    Ethicon Inc. sent an Urgent - Medical Device Correction Notification dated August 1, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this correction on hand and locate such product(s). Refer to Attachment 2 for the Product Identification Tool to identify the products that are subject to this correction by using package labels. 2. Please read Attachment 1 included within this letter thoroughly - MERSILENE" Tape Instructions for Use (IFU). 3. Ensure all users are aware of the issue by distributing this notice to all users of the Ethicon MERSILENE" Tape devices in your facility. 4. Replace the existing incorrect MERSILENE" Suture Instructions for Use (IFU) with the MERSILENE"Tape Instructions for Use (IFU) provided in Attachment 1 and dispose of the incorrect MERSILENE" Suture Instructions for Use (IFU) per your internal procedures. 5. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 1- (866) 723-2836 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this correction. 6. Keep this notice visibly posted with product subject to this correction in your facility for awareness. For further questions, please call (908) 218-0707.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.

    Quantity

    396,024 eaches