Device recall

Z-2371-2015: Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help…

FDA device recall · Class I · Elite Biomedical Solutions LLC

Key facts

Recall number (Z-number) Z-2371-2015
Recall event 71543
Product Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Product code FRN
Recalling firm Elite Biomedical Solutions LLC
Recall class Class I
Status Terminated
Termination date Mar 7, 2017
FEI number 3009712113

At a glance

  • None 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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