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Recall Observatory FDA recall evidence

Device product

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Z-1826-2015

June 04, 2015

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 71519
Status
Terminated
Classification
Class II
Quantity
1,445
Official record key
device-enforcement:Z-1826-2015

Official wording

Reason: Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

Code information: Catalo Number PR0-6F-11-038, Lot Number H767887

Distribution pattern: Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.