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
Product summary
- 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
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.