Z-1944-2024 Class II Ongoing
FDA device recall Z-1944-2024 was initiated by BD SWITZERLAND SARL on April 18, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 11.300 sets.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- April 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368