PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 16, 2022 Initiated: October 20, 2022 #Z-0223-2023

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
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, Philippines, Qatar, United Arab Emirates, and United Kingdom.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540. Recalled by CooperSurgical, Inc.. Units affected: 220,500 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0223-2023.