Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Design…

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

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 lot numbers against the lot numbers listed above. 2. If the affected Disposable Sets were consumed, please complete the attached form and return the completed form to Belmont Medical Technologies per the instructions provided on the form. No further action is required. 3. If the affected sets are in inventory, please ensure users of these devices are made aware of this notification and are provided with instructions on how to inspect and test the disposable sets prior to use. See Appendix 1. units in inventory from the identified lot numbers should be inspected immediately prior to use. Any unit identified as having cracks or leaks during priming should be discarded. Lot number of the set should be noted and reported to Belmont Medical Technologies. Actions Taken by Belmont Medical Technologies: 1. We have corrected the issue and are in the process of manufacturing products that are free of the defect listed above. Due to the full manufacturing cycle, which includes sterilization, there will be delays in availability of defect free disposable sets in the coming weeks. 2. We will replace any product found defective as soon as the product becomes available. For any questions regarding this action, technical assistance, or to report an adverse event or product complaint, please contact Belmont Medical Technologies using the following information: 1-855-387-4547 TECHSUPPORT@BELMO

• FDA enforcement recordOfficial FDA database entry for Z-1099-2025
• FDA 510(k) clearance · K242735The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Belmont Instrument LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.