Device product
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Z-1874-2024
Product summary
- Event
- Event 94304
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1874-2024
Official wording
Reason: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Code information: Lot # H2800643/ UDI: 00884450770757
Distribution pattern: Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
Derived failure modes
-
Unknown
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.