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Recall Observatory FDA recall evidence

Device product

T100-000VF, IV Set with Lower Y Site and Free Flow 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-2230-2016

June 14, 2016

Class II

Product summary

Firm
WalkMed Infusion, LLC
Event
Event 74437
Status
Terminated
Classification
Class II
Quantity
1857 cases
Official record key
device-enforcement:Z-2230-2016

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: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D

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