Recall Z-0949-2017 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle a
| Date | Jan 5, 2017 (initiated Dec 1, 2016) |
| Status | Terminated |
| Reason | Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire. |
| Root cause | Process change control |
| Action | Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representat |
| Quantity | 335 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140543 | PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER Merit Medical Systems, Inc., Oct 16, 2014 |