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
Reported: February 1, 2023 Initiated: December 22, 2022 #Z-1019-2023
Product Description
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.
Details
- Recalling Firm
- SunMed Holdings, LLC
- Units Affected
- 43,290 (Eaches)
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
- Location
- Grand Rapids, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SunMed Holdings, LLC. Units affected: 43,290 (Eaches).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2023. Severity: Moderate. Recall number: Z-1019-2023.
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