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Recall Observatory FDA recall evidence

Device product

T030-000 -30" 20 Drop IV Admin Secondary Set. 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-2222-2016

June 14, 2016

Class II

Product summary

Firm
WalkMed Infusion, LLC
Event
Event 74437
Status
Terminated
Classification
Class II
Quantity
2453 cases
Official record key
device-enforcement:Z-2222-2016

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: 020-300188. Lot Number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D

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