Z-1875-2024 Class II Ongoing
FDA device recall Z-1875-2024 was initiated by Merit Medical Systems, Inc. on Mar 14, 2024 and is designated Class II. Reason for recall: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. The recall status is ongoing. Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- Mar 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Reason for Recall
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
Code Information
Lot # H2817178/ UDI: 00884450770771
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1875-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026