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

[pending] Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check

Pending LLM rewrite. Source: FDA_DEVICE Z-1970-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

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 — Devices

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.

Related recalls

Same category