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Recall Observatory FDA recall evidence

Device product

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

Z-1874-2024

March 14, 2024

Class II

Product summary

Firm
Merit Medical Systems, Inc.
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

    reason.no_named_rule · v1.0.0

    Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.