PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: May 7, 2025 Initiated: March 31, 2025 #Z-1678-2025

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.

Details

Recalling Firm
Belmont Instrument LLC
Units Affected
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.
Location
Billerica, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Belmont Instrument LLC. Units affected: 603 cases (2,412 sets).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1678-2025.