—#81519

Product

6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, 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 product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082063
Affected lot / code info: Lot numbers: F620905, F635040, F635041, F650315, F661574, F684044, and F686778.

Why it was recalled

External tubing may separate during use, allowing blood loss.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 Merit Pkwy South, Jordan, Utah 84095

Distribution

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.

Timeline

Recall initiated: 2009-04-14
Posted by FDA: 2009-06-10
Terminated: 2010-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.