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Recall Observatory FDA recall evidence

Device product

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Z-3190-2024

August 12, 2024

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 95234
Status
Ongoing
Classification
Class II
Quantity
1892
Official record key
device-enforcement:Z-3190-2024

Official wording

Reason: 7F sheath introducers labeled as 7.5F

Code information: REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027)

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