FDAFDA · Food and drugs·Recall number Z-1875-2024
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Published May 29, 2024 · Recall initiated: March 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Lot
- Lot # H2817178/ UDI: 00884450770771
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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