Recall Z-1020-2023 ยท CAE Airway, Oropharyngeal, Anesthesiology
SunMed Holdings, LLC
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
| Date | Jan 26, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 Y |
| Quantity | 43,290 (Eaches) |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.