FDA recall Z-1019-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-12-22

Report date

2023-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2023