Recall Z-0223-2023 ยท JAY Support, Breathing Tube
CooperSurgical, Inc.
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
| Date | Nov 10, 2022 (initiated Oct 20, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| 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 do |
| Quantity | 220,500 devices |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.