Recall Z-1944-2024— BD SWITZERLAND SARL

Name: FDA recall Z-1944-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-18

Class II · Ongoing

Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2024-04-18. It names one FDA 510(k) clearance: K022209. Product: 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.. Reason: Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates..

Recalling firm: BD SWITZERLAND SARL
Classification: Class II
Status: Ongoing
Initiated: 2024-04-18
Firm location: Eysins, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETSAlaris Medical Systems, Inc.·cleared 2002-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.