Neonatal Endotracheal Tube Grip with Detachable Metal Clips Recalled
CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall with at least one reported injury (throat laceration) and multiple serious incidents including metal clip ingestion, meeting the rubric criterion for Severe.
Plain-English summary
CooperSurgical, Inc. is recalling the NEO-fit Neonatal Endotracheal Tube Grip (Part Number 42-2540) due to defects in the device's metal clips. The clips can become loose or detach from the device during use.
The company has received 11 complaints involving loose or detached metal clips. In three cases, the metal clip was ingested by the patient. In three cases, the metal clip was removed from the patient's mouth. In one case, a patient suffered a laceration to the throat.
The device has been distributed worldwide, including throughout the United States and Puerto Rico, as well as to 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 the United Kingdom. Approximately 220,500 devices have been distributed.
Healthcare providers should check whether they have units of this device and contact CooperSurgical or the FDA for information about affected lot numbers and replacement or return options. Any patient who may have been exposed to a detached clip should consult with their healthcare provider.
The recalled product
- Product
- NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 220,500
Distribution
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