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Recall Observatory FDA recall evidence

Device product

T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Z-2232-2016

June 14, 2016

Class II

Product summary

Firm
WalkMed Infusion, LLC
Event
Event 74437
Status
Terminated
Classification
Class II
Quantity
383 total cases
Official record key
device-enforcement:Z-2232-2016

Official wording

Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Code information: Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D

Distribution pattern: US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate