Merit Medical Systems, Inc. Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, 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 temporar Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, 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 temporar
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Lot number V686326.
Products Sold
Lot number V686326.
Merit Medical Systems, Inc. is recalling Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693, Merit Medi 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