One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Check against the official notice below — it lists the full affected range.
Intersurgical Inc. is recalling 21,269 units of One-Piece Guedel Airway devices (size 00, ISO 5.0, Blue) distributed nationwide across Connecticut, Florida, Indiana, Michigan, Ohio, and Virginia. The devices are being recalled because they could potentially be occluded or partially occluded, which poses a hazard to patients who depend on these oropharyngeal airways to maintain proper breathing.
The recalled devices have reference number 1100050 and are identified by specific lot numbers including 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, and 32607154. The source document does not specify what remedy or corrective action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices could potentially be occluded or partially occluded.
Reason for recall: Devices could potentially be occluded or partially occluded. Distribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA. Quantity: 21,269 units Lot/code info: REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.