Recall Z-1434-2025 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
| Date | Mar 24, 2025 (initiated Jan 27, 2025) |
| Status | Open, Classified |
| Reason | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. |
| Root cause | Packaging process control |
| Action | On 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Questions can be directed to Customer Service via email at RESPONSE@ |
| Quantity | 40 |
| Distribution | International distribution to the country of Japan. |
| 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 |