Device product

Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

Z-0783-2020

December 09, 2019

Class II

Product summary

Firm: Abbott Medical
Event: Event 84454
Status: Terminated
Classification: Class II
Quantity: 814 devices
Official record key: device-enforcement:Z-0783-2020

Official wording

Reason: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

Code information: UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

Distribution pattern: Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.