Intersurgical Inc: One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.

Hazard

Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Details from the source

Reason for recall: Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection. Distribution: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA. Quantity: 8,640 pieces Lot/code info: Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657

UPC codes

05030267153961, 5030267050680

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.