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Recall Observatory FDA recall evidence

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

April 18, 2024

Class II

Product summary

Firm
BD SWITZERLAND SARL
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

    reason.no_named_rule · v1.0.0

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