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

FDA device recall Z-1020-2023 · posted 2023-01-26 · Open, Classified

Recall details

Recalling firm

SunMed Holdings, LLC

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.

Action taken

On December 22, 2022, the firm notified affected customers through Urgent Medical Device Product Correction letters. Customers were informed that there is a discrepancy in the orogastric (OG) tube size indicated in the labeling in the instructions for use (IFU) versus the printed text on the device. Customers were provided with the correct recommended maximum OG tube/catheter sizes for each impacted Air-Q3G and Air-Q SPG model. If product has been further distributed, customers should forward the recall notice. If customers have questions about this recall notification, please contact Rob Yamashita, VP of Regulatory Affairs, at 616-259-8400, toll free at 800-433-2729, or ryamashita@sun-med.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CAE

Quantity affected

43,290 (Eaches)

Distribution

US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.

Date initiated

2022-12-22

Date posted

2023-01-26

Location

Grand Rapids, MI