AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling-sizing discrepancy affecting device marking accuracy; without reported harm and with a straightforward clinical workaround available, this qualifies as a minor labeling error.
Plain-English summary
SunMed Holdings, LLC is recalling 43,290 units of the AirQ3 Self Pressurizing Intubating Laryngeal Airway (ILA) with Automatic Cuff Inflation. The recall is due to a discrepancy in orogastric (OG) tube sizing between the Instructions for Use (IFU) labeling and the printed text on the device itself.
If a clinician is unable to pass a gastric catheter through one of the device channels, the mismatch may require using a smaller-diameter gastric catheter than indicated in the labeling. This discrepancy could affect proper device selection and use during patient care.
The affected devices were distributed nationwide to healthcare facilities in Alabama, California, Florida, Michigan, Ohio, Tennessee, Texas, and Washington. All lot sizes of the product are included in this recall.
Healthcare providers using these devices should review the actual device markings and channel dimensions in conjunction with the Instructions for Use to ensure proper catheter sizing and selection during clinical use.
The recalled product
- Product
- AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- labeling-discrepancy
- sizing-error
Distribution
Distributed nationwide across the United States.
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