Recall Z-1678-2025
Belmont Instrument LLC · initiated March 31, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911, 20241004, 20241011, 20241105
Reason for recall
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.
FDA-determined cause: Process design
Action taken
Belmont Medical notified consignees on about 03/31/2025 via "URGENT MEDICAL DEVICE CORECTION" FedEx or emailed letter. Consignees were instructed to locate affected product and to return the customer Response Form indicating if any affected units were on hand. Consignees were also instructed to follow instructions provided in the letter to inspect affected lots and if any units are identified as having cracks or leaks during priming, they should be discarded. Lot number of the set should be noted and reported to Belmont Medical Technologies. Belmont has indicated that they will replace any product found defective or at the request of the user any affected product that has not been used.
Details
- Recall number
- Z-1678-2025
- Initiated
- March 31, 2025
- Posted by FDA
- April 25, 2025
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Quantity
- 603 cases (2,412 sets)
- 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.
- Recalling firm
- Belmont Instrument LLC, Billerica, MA