Guedel airways may carry small burrs that could detach and be inhaled
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: burrs on an airway device that could detach and be inhaled, causing obstruction, with no injury reported in the source.
Plain-English summary
The one-piece Guedel airway, size 3, ISO 9.0, yellow, model number 1113090, is being recalled. The action covers 8,640 pieces, with case UDI-DI 05030267153961 and single unit UDI-DI 5030267050680.
The stated reason is potential contamination with small burrs, which if they detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was in Arizona, California, Connecticut, Florida, Hawaii, Massachusetts, Michigan, Ohio, Utah and Virginia. The airways are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Manufacturer
- Intersurgical Inc
- Affected units
- 8,640
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
Part of a larger recall action
This product is one of 2 recalled by Intersurgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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