# FDA recall Z-2453-2025

> **BD SWITZERLAND SARL** · Class II · device recall initiated 2025-06-16.

## Product

BD PhaSeal Injector Luer (N30C), REF: 515001  BD PhaSeal Injector Luer Lock (N35), REF: 515003  BD PhaSeal Injector Luer Lock (N35C), REF: 515004  BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005  BD PhaSeal Protector (P14), REF: 515100  BD PhaSeal Protector (P21), REF: 515102  BD PhaSeal Protector (P21 Multi), REF: 515103  BD PhaSeal Protector (P28), REF: 515104  BD PhaSeal Protector (P50), REF: 515105  BD PhaSeal Protector (P50 Multi), REF: 515106  BD PhaSeal Protector (P53), REF: 515107  BD PhaSeal Protector (P55), REF: 515117  BD PhaSeal Connector Luer Lock (C35), REF: 515200  BD PhaSeal Connector Luer Lock (C45), REF: 515202  BD PhaSeal Y-site Connector (C80), REF: 515304  BD PhaSeal L Connector (C90), REF: 515305  BD PhaSeal Infusion Adapter (C100), REF: 515306  BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307  BD PhaSeal Cap for Injector (M50), REF: 515404  BD PhaSeal Connector Cap (M70), REF: 515406  BD PhaSeal Optima Injector (N35-O), REF: 515052  BD PhaSeal Opti

## Reason for recall

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

## Distribution

US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.

## Key facts

- **Recall number:** Z-2453-2025
- **Recalling firm:** BD SWITZERLAND SARL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-16
- **Report date:** 2025-09-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2025

## Citation

> AI Analytics. FDA recall Z-2453-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2453-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*