United StatesIntersurgical One‑Piece Guedel Oropharyngeal Airway devices — size 00 (ISO 5.0, blue; REF 1100050; Single Unit UDI 5030267050185; Case UDI 05030267044450; lots 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154) and size 000 (ISO 3.5, light green; REF 1000035; Single Unit UDI 5030267049844; Case UDI 05030267044528; lots 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565) distributed in CT, FL, IN, MI, OH and VA are affected. The devices were recalled because they could potentially be occluded or partially occluded.
What's being recalled
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Recalling firm: Intersurgical Inc, East Syracuse, NY, United States.
How to identify it
REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
The hazard
Devices could potentially be occluded or partially occluded.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)