Reported Nov 16, 2022 · Ongoing
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
- Lot codes and dates
- Lot/Serial Number UDI-DI (GTIN-14 - not yet added to GUDID database)
112 of 112 codes
272992008889370166592694760088893701665926947700888937016659269478008889370166592694790088893701665926948000888937016659269482008889370166592694830088893701665927495700888937016659274958008889370166592749600088893701665927496100888937016659286859008889370166592868610088893701665928686300888937016659292881008889370166592928830088893701665929288800888937016659292889008889370166592929000088893701665929290100888937016659292903008889370166592962360088893701665929623800888937016659297033008889370166592970340088893701665929703500888937016659298049008889370166592980550088893701665929805400888937016659
- Lot/Serial Number UDI-DI (GTIN-14 - not yet added to GUDID database)
- Amount recalled
- 220,500 devices
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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