Device 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.
Z-1944-2024
Product summary
- Event
- Event 94479
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11.300 sets
- Official record key
device-enforcement:Z-1944-2024
Official wording
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.
Code information: Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
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.
Derived failure modes
-
Unknown
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.