Recall Z-1874-2024 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
| Date | May 20, 2024 (initiated Mar 14, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
| Root cause | Employee error |
| Action | On March 18, 2024 Merit Medical issued a "Urgent Medical Device Recall Notice to affected consignees via E-Mail. Merit Medical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is im |
| Quantity | 18 units |
| Distribution | Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211405 | Prelude Guide Sheath Merit Medical Systems, Inc., Oct 4, 2021 |