Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF ...

FDA Device Recall #Z-1944-2024 — Class II — April 18, 2024

Recall Summary

Recall Number Z-1944-2024
Classification Class II — Moderate risk
Date Initiated April 18, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm BD SWITZERLAND SARL
Location Eysins, N/A
Product Type Devices
Quantity 11.300 sets

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.

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.

Lot / Code Information

Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

Other Recalls from BD SWITZERLAND SARL

Recall # Classification Product Date
Z-2453-2025 Class II BD PhaSeal Injector Luer (N30C), REF: 515001 B... Jun 16, 2025
Z-1973-2025 Class II BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... May 12, 2025
Z-1971-2025 Class II BD Texium Needle-Free Syringe: 3 mL, REF: MY800... May 12, 2025
Z-1974-2025 Class II BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... May 12, 2025
Z-1970-2025 Class II Alaris Pump Infusion Set: SmartSite Bag Access... May 12, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.