Recall Z-1409-2009 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
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 acces
| Date | Jun 10, 2009 (initiated Apr 14, 2009) |
| Status | Terminated |
| Reason | External tubing may separate during use, allowing blood loss. |
| Root cause | Process control |
| 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. |
| Quantity | 5781 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082063 | PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc., Oct 15, 2008 |