Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Alaris Pump Recalled by CareFusion 303, Inc. Due to The bezel manufacturing process for the FR-110 plastic...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 303, Inc. directly.
Affected Products
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. There are 6 bezel posts on the Alaris Pump bezel assembly.
Quantity: 607618
Why Was This Recalled?
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CareFusion 303, Inc.
CareFusion 303, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report