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Recall Observatory FDA recall evidence

Device product

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Z-0027-2020

October 26, 2018

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 83738
Status
Terminated
Classification
Class II
Quantity
24 kits
Official record key
device-enforcement:Z-0027-2020

Official wording

Reason: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Code information: Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Distribution pattern: U.S.: VA, IL

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error