The Recall Desk
HighFDA (Devices)·Z-2459-2021·Announced 2021-09-22

BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

What this means for you

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: FDA Class II device recall for a risk-of-harm product where operational defects could delay patient therapy. No illnesses or injuries have been reported, which places it below the Class II recalls requiring hospitalization or significant injury reports. This fits the rubric criterion: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carefusion is recalling BD Alaris Pump Infusion Buerette Sets with needle-free connector valves. The affected products include multiple configurations with reference numbers such as 10015012, 10817920, 10821753, 11607787, 11613191, 2440-0600, 2441-0007, 2444-0007, 2447-0007, and C24104E, with lot numbers spanning the 20000 and 21000 series.

The needle-free connector valves may experience difficulty flushing, reduced flow, or partial to total occlusions. These operational issues could lead to delays in therapy delivery to patients.

Approximately 344,300 units have been distributed worldwide, including throughout the United States and to multiple countries including Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil. No illnesses or injuries have been reported.

Follow-up actions are not required if the product has already been used or was safely connected to the female luer of the connecting device. Contact Carefusion for additional guidance regarding your specific lot numbers.

The recalled product

Product
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
Manufacturer
CAREFUSION
Category
Medical Device — Infusion pump connector sets
Hazard
  • occlusion
  • flow-issue
  • therapy-delay

Distribution

Distributed nationwide across the United States.

Related recalls

Same category