Z-0658-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- November 5, 2018
- Termination Date
- April 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,097 cs x 12 units each
Product Description
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Reason for Recall
Potential for external blood leaks from the dialyzer header
Distribution Pattern
US Nationwide
Code Information
Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019