Merit Medical Systems, Inc. 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 hemodia Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 hemodia
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Lot numbers: F651361 and F661593.
Products Sold
Lot numbers: F651361 and F661593.
Merit Medical Systems, Inc. is recalling 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.0 due to External tubing may separate during use, allowing blood loss.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
External tubing may separate during use, allowing blood loss.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, GA, IL, MO, OK, OR
Page updated: Jan 10, 2026