FDA-Device2022-11-16Class II
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
CooperSurgical, Inc.
Hazard
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.
Sold states
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.
Affected count
220,500 devices
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2023Don't want to check this manually?
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