Recall Z-1956-2020 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
| Date | Sep 12, 2019 |
| Status | Terminated |
| Reason | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism. |
| Root cause | Process control |
| Action | A verbal (telephone) notification attempt was made to the customer on September 12th and 13th. These attempts resulted in a voicemail informing the customer of a voluntary product recall and requesting a call back. A hospital employee was reached by telephone on September 17, 2019 and notified of the product recall. The notification included product identification information, instruction to immediately quarantine any devices and to discontinue use and to return product to Merit per the instructions contained in the Customer Response Form (CRF). The CRF and details of the recall were emailed t |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution in the state of MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc., Feb 15, 2018 |