BEUDAMED
    FDA Recall Terminated

    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

    Recall: Z-2287-2018 · Initiated June 12, 2018

    Recall

    Recall Number
    Z-2287-2018
    Event Number
    80279
    Firm
    Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
    FEI Number
    3007134520
    Product Code
    LRW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 12, 2018
    Posted
    June 14, 2018
    Terminated
    April 2, 2021

    Description

    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

    Reason

    The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.

    Action

    The firm initiated the recall by letter on 06/12/2018. All affected consignees are instructed to take the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter."

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, India

    Quantity

    573 units