Becton Dickinson (BD) (CareFusion 303, Inc.) has decided to recall Alaris Pump Module Model 8100 Bezel Assembly manufactured between April 2011 and June 2017. The FDA has identified this recall as class Ⅰ recall, the most serious type of recall.
The device is an infusion pump that delivers fluids including medications, blood and blood products, into a patient’s body in controlled amounts. The fluids are administered via an infusion tubing set into a patient’s vein or through other cleared routes of administration.
Six bezel posts are used to connect the pumping mechanism frame to bezel assembly and are critical to proper performance of the pump. Hospitals and other health care facilities use this device.
The device is being recalled because the bezel posts may become cracked and separated from the assembly which could lead to inaccurate delivery of fluids to the patient. From 2011-2017, the Alaris Pump Module Model 8100 was manufactured with FR-110 plastic.
The plastic weakens during its manufacturing process, which may lead to separation of bezel post from the pumping mechanism or lead to cracking and this can lead to over-infusion, under-infusion, free-flow state, or infusion’s interruption.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like