Intersurgical Recalls One-Piece Guedel Airway Devices Due to Occlusion Risk
Intersurgical Inc is recalling 1,575 One-Piece Guedel Airway devices because they could potentially be occluded or partially occluded.
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 involves a medical device with a functional defect (occlusion) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intersurgical Inc is recalling 1,575 units of One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. These are oropharyngeal airway devices used in medical settings.
The recall was initiated because the devices could potentially be occluded or partially occluded. This defect could interfere with the device's intended function.
The affected products were distributed nationwide in the states of Connecticut, Florida, Indiana, Michigan, Ohio, and Virginia. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Manufacturer
- Intersurgical Inc
- Hazard
- Affected units
- 1,575
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 (11)
- REF: 1000035
- Single Unit UDI: 5030267049844
- Case UDI: 05030267044528
- Lot No. 32190425
- 32213076
- 32221283
- 32307261
- 32317627
- 32321305
- 32513841
- 32517565.
Distribution
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