Z-1678-2025 Class II Ongoing
FDA device recall Z-1678-2025 was initiated by Belmont Instrument LLC on March 31, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 603 cases (2,412 sets).
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 603 cases (2,412 sets)
Product Description
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.
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.
Distribution Pattern
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.
Code Information
Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911, 20241004, 20241011, 20241105