FDA-Device2023-02-01Class II
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
SunMed Holdings, LLC
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.
Sold states
US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Affected count
43,290 (Eaches)
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2023Don't want to check this manually?
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