BD Alaris Pump Infusion Sets Contain Undisclosed DEHP
BD Alaris Pump infusion sets labeled as DEHP-free actually contain di(2-ethylhexyl) phthalate. The worldwide recall affects multiple catalog numbers distributed throughout the US and internationally.
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: This is a Class II recall involving a known hazardous substance (DEHP) in products labeled as free from it. While no illnesses or injuries have been reported, DEHP poses documented reproductive and developmental health risks, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling multiple BD Alaris Pump infusion sets due to a labeling discrepancy. The affected sets are labeled as free of di(2-ethylhexyl) phthalate (DEHP), but they actually contain DEHP.
DEHP is a phthalate chemical that poses health concerns, particularly regarding reproductive and developmental effects. Medical professionals and patients relying on the DEHP-free labeling may unknowingly expose patients to this substance during infusion therapy.
The recall affects numerous catalog numbers of BD Alaris infusion sets distributed worldwide, including throughout the United States in all 50 states, Washington DC, Puerto Rico, and Guam, as well as internationally to Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates. All lots with expiration dates through July 31, 2026 are included.
Healthcare facilities should immediately discontinue use of the affected infusion sets and contact BD customer service for guidance on replacement products. Consult with your healthcare provider regarding any potential exposure.
The recalled product
- Product
- BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD Alar
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Sets
- Hazard
- dehp
- mis-labeling
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 (20)
- UDI-DI: 10885403232602
- Catalog # 10010483
- UDI-DI: 07613203021135
- Catalog # 10010453
- UDI-DI: 07613203015806
- Catalog # 10010454
- UDI-DI: 07613203021210
- Catalog # 10013072
- UDI-DI: 10885403221965
- Catalog # 10013361
- UDI-DI: 10885403232268
- Catalog # 10013890
- UDI-DI: 10885403233951
- Catalog # 10015012
- UDI-DI: 10885403221866
- Catalog # 10015862
- UDI-DI: 07613203019668
- Catalog # 10062818
- UDI-DI: 07613203019187
- Catalog # 10821753
Distribution
Distributed nationwide across the United States.
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