Belmont Instrument LLC 2025-05-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1678-2025
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032… Recall
Issued May 7, 2025 · Belmont Instrument LLC
In May 2025, Belmont Instrument LLC recalled the 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
What you should do
- 1 Stop using 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Belmont Instrument 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
- Belmont Instrument LLC
- Category
- Health
- Recall date
- May 7, 2025
- Units affected
- Not reported
- Sold at
- Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, T
- Recall number
- FDA-Z-1678-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Belmont Instrument LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.