Agency classClass IIOur severity:High FDA (Devices)·Z-2466-2021·Announced 2021-09-22

BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a risk-of-harm product (infusion pump connector that could delay therapy). Per the rubric, such products where injury has not yet been reported score 3 (High).

Plain-English summary

BD Alaris Pump Infusion Buerette Set Smallbore Tubing with Smartsite Port (Burette) needle-free connector valves, model REF: 2441-0006, are being recalled due to potential issues with the connector valves.

The needle-free connector valves may experience difficulty flushing, flow issues, and partial or total occlusions. These issues could result in delays to patient therapy administration.

The recalled product was manufactured by CAREFUSION and distributed worldwide. In the United States, distribution included all 50 states, Puerto Rico, and Washington D.C. International distribution included Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil. The recall involves lot numbers 20077170, 20077171, 20077319, and 20077320.

Follow-up action is not required if the product has already been used or was safely connected to a female luer connector. Those with unused affected product should verify proper function and connectivity before use.

The recalled product

Product: BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Manufacturer: CAREFUSION
Category: Medical Device — Infusion Pump Connector
Hazard: occlusion
flow-restriction
therapy-delay
Affected units: 270

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lots: 20077170 20077171 20077319 20077320

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 15 recalled by CAREFUSION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Same manufacturer · CAREFUSION

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Same hazard · occlusion