BD SWITZERLAND SARL: Device Recall

Recall Details

Recall Number

Z-1509-2025

Classification

Class II

Product Type

Device

Recalling Firm

BD SWITZERLAND SARL

Status

Ongoing

Date Initiated

02/20/2025

Location

Eysins, Switzerland

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

500 units

Reason for Recall

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Product Description

BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.

Distribution Pattern

U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A

Other Recalls by BD SWITZERLAND SARL

• Class II: Risk 06/16/2025
  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.
• Class II: Risk 05/12/2025
  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.
• Class II: Risk 05/12/2025
  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.
• Class II: Risk 05/12/2025
  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.
• Class II: Risk 05/12/2025
  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.

View all recalls by BD SWITZERLAND SARL →