BEUDAMED
    FDA Recall Terminated

    Suture removal kit, catalog# 900-010

    Recall: Z-1251-2012 · Initiated December 8, 2011

    Recall

    Recall Number
    Z-1251-2012
    Event Number
    60753
    Firm
    Customed, Inc Calle Igualdad Final # 7
    FEI Number
    2648727
    Product Code
    MCZ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 8, 2011
    Posted
    March 21, 2012
    Terminated
    April 12, 2017
    Address
    Fajardo, PR, 00738

    Description

    Suture removal kit, catalog# 900-010

    Reason

    The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.

    Action

    Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.

    Distribution

    USA Nationwide Distribution - including Florida and Puerto Rico.

    Quantity

    45,200