8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.
FDA Recall Z-1413-2009 · Posted 2009-06-10
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2009-04-14
Date Terminated2010-02-09
Product Quantity68 units
Reason for Recall
External tubing may separate during use, allowing blood loss.
Firm Action
All of Merit's US sales representatives and distributors were notified by Prelude Short Sheath Introducer - Product Recall letter on 4/14/2009. They were instructed to promptly contact their customers. Customers were instructed to isolate, remove from inventory, and return all affected inventory. A Product Retrieval Form was to be returned to Merit. Further information is available at 801-316-4998 or 801-208-4344.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, including states of CA, CO, GA, IL, MO, OK, and OR and countries of Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Japan, Latvia, Lithuania, Netherlands, New Zealand, Spain, Sweden, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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