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 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
00814954020263, 10814954020260, 20814954020267, 00814954020270, 10814954020277, 20814954020274, 00814954020287, 10814954021083, 20814954020281, 00814954020294, 10814954021090, 20814954020298, 00814954020300, 10814954021106, 20814954020304, 00814954020317, 10814954021113, 20814954020311, 00814954020324, 10814954021120, 20814954020328
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.