Class 2 Device Recall 3Spike Disposable Set

• Date Initiated by Firm: January 02, 2025
• Date Posted: February 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1099-2025
• Recall Event ID: 96092
• 510(K)Number: K242735
• Product Classification: Pump, infusion - Product Code FRN
• 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
• Code Information: UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014
• Recalling Firm/ Manufacturer: Belmont Instrument LLC ; 780 Boston Rd; Billerica MA 01821-5925
• For Additional Information Contact: SAME; 978-663-0212
• Manufacturer 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
• FDA Determined 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 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
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN