Z-0783-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2020
- Initiation Date
- December 9, 2019
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 814 devices
Product Description
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Reason for Recall
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
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
Code Information
UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555