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Open, Classified

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

FDA Recall Z-1020-2023 · Posted 2023-01-26

Recalling FirmSunMed Holdings, LLC
Recall StatusOpen, Classified
Product CodeCAE
Date Initiated2022-12-22
Product Quantity43,290 (Eaches)

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.

Firm Action

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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