BEUDAMED
    FDA Recall Open, Classified

    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

    Recall: Z-0223-2023 · Initiated October 20, 2022

    Recall

    Recall Number
    Z-0223-2023
    Event Number
    91047
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    JAY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 20, 2022
    Posted
    November 10, 2022
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

    Reason

    Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.

    Action

    On October 20, 2022, the firm notified affected customers via "URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE" letters dated 10/7/2022. Customers were instructed to quarantine all affected product and complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory (or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. CooperSurgical will then arrange for the return of the affected product at no additional cost to the customer. Customers will receive a credit for returned product. If you have any questions, please feel free to reach us at 203-601-5200 ext. 3300 or [email protected].

    Distribution

    Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey, Philippines, Qatar, United Arab Emirates, and United Kingdom.

    Quantity

    220,500 devices