Skip to content
Recall Observatory FDA recall evidence

Device product

Custom Procedure Kit, REF: K12T-11077

Z-3191-2024

August 12, 2024

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 95234
Status
Ongoing
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-3191-2024

Official wording

Reason: 7F sheath introducers labeled as 7.5F

Code information: REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024)

Distribution pattern: Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    7F sheath introducers labeled as 7.5F