Z-1099-2025Class II

Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in...

Name: Z-1099-2025 Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in...
Creator: Belmont Instrument LLC
Published: 2025-01-02
License: https://open.fda.gov/license/

Belmont Medical Technologies / initiated 2025-01-02 / Open, Classified / root cause: manufacturing process

FDA source

Belmont Instrument LLC began a recall of 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... on 2025-01-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1099-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-02
Posted: 2025-02-04
Recalling firm: Belmont Medical Technologies
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
Product code: FRN Pump, Infusion
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
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

Product code FRN

K242735Class IIBelmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)Belmont Medical Technologies / cleared 2024-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)