Recall Z-1099-2025— Belmont Instrument LLC
Class II · Ongoing
Class II FDA medical device recall by Belmont Instrument LLC, initiated 2025-01-02. It names one FDA 510(k) clearance: K242735. Product: Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006. Reason: Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set.
- Recalling firm
- Belmont Instrument LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-02
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
Reason for recall
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Data sourced from openFDA. This site is unofficial and independent of the FDA.