Becton Dickinson is recalling the Alaris Pump Model 8100 Infusion Sets and the FDA has identified this as class Ⅰ recall, the most serious type of recall.
These Infusion Sets are used with an infusion pump to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. The fluid is administered via an infusion tubing set into a patient's vein or through other cleared routes of administration.
The sets have same components that are commonly found on intravascular administration sets and extension sets. Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male Luer with spin lock, and tubing of different lengths are the components of these sets.
The sets are being recalled due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status”. The silicone segment of the affected set has non-uniform wall thickness, which may lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing.
Mr Vinod Arora, Principal Advisor, IGMPI
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