Device recall

Z-1099-2025: Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2…

FDA device recall · Class II · Belmont Instrument LLC

Key facts

Recall number (Z-number) Z-1099-2025
Recall event 96092
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
Recalling firm Belmont Instrument LLC
Recall class Class II
Status Open, Classified
510(k) numbers K242735
FEI number 1219702

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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