Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (airway occlusion) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Intersurgical Inc is recalling 21,269 units of One-Piece Guedel Airway, size 00, ISO 5.0, Blue. These are oropharyngeal airway devices used in medical settings. The recall was initiated because the devices could potentially be occluded or partially occluded.
The affected devices were distributed nationwide in the United States, specifically in the states of Connecticut, Florida, Indiana, Michigan, Ohio, and Virginia. The recall covers specific lot numbers and reference numbers, including REF 1100050 and various lot numbers such as 32121232 and 32208193.
Healthcare facilities and consumers should stop using the affected devices and contact Intersurgical Inc for further instructions. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Manufacturer
- Intersurgical Inc
- Hazard
- Affected units
- 21,269
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 (15)
- REF: 1100050
- Single Unit UDI: 5030267050185
- Case UDI: 05030267044450
- Lot No. 32121232
- 32208193
- 32400267
- 32403734
- 32408819
- 32409672
- 32416545
- 32427064
- 32605471
- 32606405
- 32606850
- 32607154.
Distribution
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