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
- Affected units
- 344,300
Distribution
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 →Related recalls
Same manufacturer · CAREFUSION
See all →- HighBD MaxGuard Extension Set Recalled for Incorrect Expiration Year
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
FDA (Devices) · 2022-09-28
Same hazard · occlusion
See all →- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- HighIV set 490315 recalled over backflow between primary and secondary containers
FDA (Devices) · 2025-12-03
- HighIV set 490067 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490385 recalled over medication backflow between IV containers
FDA (Devices) · 2025-12-03
- HighIV set 490519 recalled over piggyback backflow and priming occlusion
FDA (Devices) · 2025-12-03