BD SWITZERLAND SARL: Device Recall

Recall Details

Recall Number

Z-1944-2024

Classification

Class II

Product Type

Device

Recalling Firm

BD SWITZERLAND SARL

Status

Ongoing

Date Initiated

04/18/2024

Location

Eysins, N/A, Switzerland

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11.300 sets

Reason for Recall

Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

Product Description

Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.

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 →