FDAFDA · Food and drugs·Recall number Z-1019-2023
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
Published February 1, 2023 · Recall initiated: December 22, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SunMed Holdings, LLC
- Distributor
- US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
- Lot
- ALL LOTS Size REF UDI/DI 0.0 50005 Each: 00814954020188 Box: 10814954020185 Case: 20814954020182 0.5 50055 Each: 00814954020195 Box: 10814954020192 Case: 20814954020199 1.0 50105 Each: 00814954020201 Box: 10814954021007 Case: 20814954020205 1.5 50155 Each: 00814954020218 Box: 10814954021014 Case: 20814954020212 2.0 50205 Each: 00814954020225 Box: 10814954021021 Case: 20814954020229 3.0 50305 Each: 00814954020232 Box: 10814954021038 Case: 20814954020236 4.0 50405 Each: 00814954020249 Box: 10814954021045 Case: 20814954020243
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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