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SunMed Holdings, LLC recalls AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5
Recalled February 1, 2023 · FDA recall Z-1020-2023 · SunMed Holdings
Hazard
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. · FDA Class II
Units
43,290 (Eaches)
Sold at
US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Description
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.
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(s)
SunMed Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →