Recall Z-1099-2025 ยท FRN Pump, Infusion
Belmont Instrument LLC
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
| Date | Feb 4, 2025 (initiated Jan 2, 2025) |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | Belmont Medical Technologies issued Urgent Medical Device Correction letter via FedEx to all affected Medical User facilities and US distributors on January 2, 2025. Additionally, email with the notification letter is being emailed to all purchasing agents requesting forwarding the information to the appropriate departments in their organization. Foreign distributors will be notified via email once translations of the communications are completed. Letter states reason for recall, health risk and action to take: 1. Locate the Disposable Sets (P/N 903-00006) in your possession and check their |
| Quantity | 1,029 cases (12,348 sets) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/m Belmont Medical Technologies, Dec 23, 2024 |