Device product
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Z-2275-2025
Product summary
- Event
- Event 97127
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,800 pieces
- Official record key
device-enforcement:Z-2275-2025
Official wording
Reason: 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.
Code information: Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Distribution pattern: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Derived failure modes
-
Unknown
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.