# FDA recall Z-1970-2025

> **BD SWITZERLAND SARL** · Class II · device recall initiated 2025-05-12.

## 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 Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T;  Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T;  SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T;  SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T;   SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T;  Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T;  SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.

## Key facts

- **Recall number:** Z-1970-2025
- **Recalling firm:** BD SWITZERLAND SARL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-12
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eysins, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1970-2025

## Citation

> AI Analytics. FDA recall Z-1970-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1970-2025. Source: US FDA. Licensed CC0.

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