Recall archive / FDA device enforcement
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY — FDA record Z-1875-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
- Reason
- Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
- Classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 27 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1875-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # H2817178/ UDI: 00884450770771 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 29, 2024
- Recall initiation date
- Mar 14, 2024
- Center classification date
- May 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.