SunMed recalls AirQ3 Self-Pressurizing ILA devices due to incorrect gastric tube size labeling. This mismatch may prevent proper catheter insertion, requiring smaller tubes in some cases.
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 AirQ3 Self-Pressurizing ILA devices because the labeled gastric tube size differs from the actual device. This mismatch could cause clinicians to use smaller catheters than intended, potentially leading to improper medical procedures.
The device labels show a different gastric tube size than what's printed on the device itself. If a clinician can't pass a standard gastric catheter through the channel, they might need to use a smaller-diameter tube, which could lead to improper insertion or complications.
Healthcare providers using the AirQ3 devices for gastric tube insertion are most at risk. Patients receiving care through these devices may be affected if the tube size discrepancy impacts treatment.
Check for the AirQ3 Self-Pressurizing ILA with Automatic Cuff Inflation and GA Size. The device has REF numbers: 0.0-60005, 0.5-60055, 1.0-60105, 1.5-60155, 2.0-60205, 3.0-60305, or 4.0-60405.
Verify the gastric tube size printed on the device matches the REF number listed in the product description.
The device labels show a different gastric tube size than what's printed on the device itself, which could lead to using smaller catheters than intended.
Check the device labeling against the REF number to confirm the size. No action is required if the sizes match.
The recall addresses a potential mismatch in tube size, but the hazard does not involve immediate risks like injury or death. The risk is low and requires specific clinical conditions.
We’ve drafted a message you can send SunMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1020-2023 — SunMed SunMed Hello, I own a SunMed that is covered by recall Z-1020-2023 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.
