SunMed Holdings, LLC 2023-11-29 Health serious FDA
Health · FDA · Recall #FDA-Z-0369-2024
Medline manual resuscitators with integrated manometer, multiple accessory configurations… Recall
Issued November 29, 2023 · SunMed Holdings, LLC
In November 2023, SunMed Holdings, LLC recalled the Medline manual resuscitators with integrated manometer, multiple accessory configurations…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
What you should do
- 1 Stop using Medline manual resuscitators with integrated manometer, multiple accessory configurations… 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
- November 29, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, N
- Recall number
- FDA-Z-0369-2024
- 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.