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.
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. Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. Quantity: 43,290 (Eaches) Lot/code info: 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
00814954020188, 10814954020185, 20814954020182, 00814954020195, 10814954020192, 20814954020199, 00814954020201, 10814954021007, 20814954020205, 00814954020218, 10814954021014, 20814954020212, 00814954020225, 10814954021021, 20814954020229, 00814954020232, 10814954021038, 20814954020236, 00814954020249, 10814954021045, 20814954020243
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.