BEUDAMED
    FDA Recall Open, Classified

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    Recall: Z-1430-2023 · Initiated February 23, 2023

    Recall

    Recall Number
    Z-1430-2023
    Event Number
    91968
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    FSM
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    February 23, 2023
    Posted
    April 25, 2023
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    Reason

    Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

    Action

    Aesculap Implant Systems, LLC, issued Urgent Medical Device Recall Notification letter on 2/23/23. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility. cease use and guarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Recall Acknowledgement Form," record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Recall Acknowledgment Form" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA QualityAssurance.BBMUS [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you to arrange for shipment of a replacement lid and to have your current inventory returned.

    Distribution

    US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.

    Quantity

    ME754: 3 units; ME764: 22 units