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Belmont Medical 3-Spike Disposable Set used with the… recallZ-1099-2025 · Belmont Instrument LLC · initiated Jan 2, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Belmont Instrument LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-1099-2025
Status
Open, Classified
Initiated by the company
Jan 2, 2025
Posted by the FDA
Feb 4, 2025
Recalling firm
Belmont Instrument LLC
Quantity
1,029 cases (12,348 sets)
Product code
FRN
FDA submissions
K242735
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.

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

Code information (models, lots, serial numbers)

UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

7 devices cleared under K242735 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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