SunMed Holdings, LLC 2023-02-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1019-2023
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number … Recall
Issued February 1, 2023 · SunMed Holdings, LLC
In February 2023, SunMed Holdings, LLC recalled the Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SunMed Holdings, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SunMed Holdings, LLC
- Category
- Health
- Recall date
- February 1, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
- Recall number
- FDA-Z-1019-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- SunMed Holdings, LLC has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.