SunMed recalls Air-Q3 Standard ILA devices with manual cuff inflation due to inconsistent gastric tube size labeling, potentially causing improper catheter insertion.
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
SunMed is recalling Air-Q3 Standard ILA devices with manual cuff inflation because the labeling of gastric tube sizes doesn't match the actual device. This mismatch could lead to clinicians using the wrong tube size, which might cause improper catheter insertion during medical procedures.
The device labels show a gastric tube size that differs from the actual tube size. If a clinician can't pass a gastric catheter through the channel, they might use a smaller-diameter tube, which could lead to improper insertion or complications.
Healthcare providers using the Air-Q3 devices for gastric intubation are most at risk. Patients receiving these devices during medical procedures may be affected if the tube size is incorrect.
Check for the Air-Q3 Standard ILA with Manual Cuff Inflation and GA Size. The device has REF numbers: 0.0 50005, 0.5 50055, 1.0 50105, 1.5 50155, or 2.0 50205.
Verify the gastric tube size printed on the device matches the labeling in the instructions for use.
The device has an orogastric tube size discrepancy between the labeling in the instructions and the printed text on the device, which could lead to using a smaller-diameter gastric catheter if the clinician can't pass a standard tube.
Check the device labeling against the instructions for use to ensure the gastric tube size matches. If there's a discrepancy, contact SunMed for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send SunMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1019-2023 — SunMed SunMed Hello, I own a SunMed that is covered by recall Z-1019-2023 from SunMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
