Recall Z-1020-2023— SunMed Holdings, LLC
Class II · Ongoing
Class II FDA medical device recall by SunMed Holdings, LLC, initiated 2022-12-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..
- Recalling firm
- SunMed Holdings, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-22
- Firm location
- Grand Rapids, MI, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.