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Recall Observatory FDA recall evidence

Device product

SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

Z-0450-2014

November 08, 2013

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 66759
Status
Terminated
Classification
Class II
Quantity
480 units
Official record key
device-enforcement:Z-0450-2014

Official wording

Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

Code information: Lot No: 13046215 13046641 13056285 13056577 13075931

Distribution pattern: US Distribution in CA, WY, OH, UT, and MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.