Recall Z-1826-2015 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Merit Medical Systems, Inc.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended 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.
| Date | Jun 22, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038. |
| Root cause | Packaging process control |
| Action | Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sen |
| Quantity | 1,445 |
| Distribution | Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070159 | PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc., Jun 21, 2007 |