The Recall Desk
HighFDA (Devices)·Z-1970-2025·Announced 2025-06-18

Alaris Pump Infusion Sets may leak at male luer connections

BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.

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 an FDA Class II recall of a critical drug delivery device with a risk-of-harm defect (leaks that could cause treatment interruptions, exposure to hazardous drugs, and underdosing). The source text explicitly states potential harms but does not report any illnesses or injuries; therefore, the score is High per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

BD SWITZERLAND SARL is recalling multiple Alaris Pump Infusion Set models due to a potential leak at the interface between the closed male luer component and the needle-free connector. The affected product includes multiple reference numbers (REF: 10013361T, 10321213T, 22000-B007T, 22600-0007T, 22602-B007T, 22603-B007T, 24010-0007T, 24301-0007T, 24601-B007T, 70001B-07T, 20350ET, 40000-07T, 10013364T, 4030B-07T, and 22005E-07T) distributed worldwide and throughout the United States.

This defect may cause procedure delays, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication. These are sterile, single-use closed system drug transfer devices used either standalone, on infusion sets, or bonded syringes.

Patients and healthcare providers who have these infusion sets should contact their healthcare facility or BD SWITZERLAND SARL for further instructions regarding affected lot numbers and expiration dates. Healthcare facilities should review the detailed lot and UDI-DI information provided in the recall notice to identify affected inventory.

The recalled product

Product
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Infusion Set / Drug Delivery System
Hazard
  • leakage
  • drug-exposure
  • underdosing
  • treatment-interruption

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)

  • REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10
  • 2026)
  • 23035235(March 11
  • 23045223(April 6
  • 23075395(July 17
  • 23085227(August 8
  • 23115150(November 8
  • 23115151(November 8
  • 23125167(December 5
  • 24025684(February 6
  • 2027)
  • 24045377(April 23
  • 24055576(May 27
  • 24075224(July 26
  • 24105079(October 11
  • 24115159(November 7
  • 10321213T/10885403228971/23035169(March 15
  • 23045174(April 4
  • 23085140(August 3
  • 23095142(September 11

Distribution

Distributed nationwide across the United States.

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