Guedel Airway Size 3 Recalled Due to Potential Burr Contamination
Intersurgical Inc is recalling Guedel Airway Size 3 (Model 1113090) due to potential contamination with small burrs that could detach and be inhaled, causing airway obstruction or tissue damage. Approximately 8,640 units were affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a risk-of-harm product (critical airway management device) where the potential exists for serious complications such as airway obstruction or infection if contaminated units are used. No illnesses or injuries have been reported to date.
Plain-English summary
Intersurgical Inc has issued a recall of Guedel Airway Size 3, Model 1113090 (UDI-DI: 5030267050680), due to potential contamination with small burrs. These burrs could detach if the product is used, potentially being inhaled and causing airway obstruction, tissue irritation, inflammation, or infection.
The recall affects 8,640 units with Lot Number 32420657. The product was distributed to healthcare facilities in Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah, and Virginia.
Healthcare providers and facilities in affected states should immediately discontinue use of the recalled airway and remove it from inventory. Institutions should follow their medical device handling and disposal procedures for affected units. Patients who received this device should contact their healthcare provider if they have concerns.
The recalled product
- Product
- One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Manufacturer
- Intersurgical Inc
- Hazard
- burr-contamination
- airway-obstruction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: 1113090. UDI-DI (Case): 05030267153961
- UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Distribution
Distributed in 10 states:
- AZ
- CA
- CT
- FL
- HI
- MA
- MI
- OH
- UT
- VA
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