AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 ...
FDA Recall #Z-1020-2023 — Class II — December 22, 2022
Product Description
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
Reason for Recall
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.
Recalling Firm
SunMed Holdings, LLC — Grand Rapids, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
43,290 (Eaches)
Distribution
US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Code Information
ALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated