FDA Medical devices recall ·
3.0 Liter Disposable Set (4 sets/case) recall
- Recall number
- Z-1678-2025
- Date
- (initiated March 31, 2025)
- Company / brand
- Belmont Instrument LLC
780 Boston Rd, Billerica, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 603 cases (2,412 sets)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911, 20241004, 20241011, 20241105
Distribution
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, TX, UT, VA, WA, WI. International distribution to Czechia, Italy, Norway.
States: Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri North Carolina North Dakota Nebraska New Jersey Nevada New York Ohio Oregon Pennsylvania South Carolina Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1678-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.