FDA Medical devices recall ·
Hyperthermia Pump Procedure Kit recall
- Recall number
- Z-1674-2025
- 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
- 158 sets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Why was it recalled?
Potential crack in the female connector located on the Heat Exchanger in the 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: 902-00045. UDI-DI: 00896128002589. Lot Numbers: 20241005, 20241108
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.
States: Arizona California Colorado Connecticut District of Columbia Illinois Indiana Kansas Kentucky Massachusetts Maine Minnesota North Carolina North Dakota New Jersey New Mexico Ohio Oregon Pennsylvania South Carolina Tennessee Texas Virginia Vermont Washington Wisconsin West Virginia
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-1674-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.