Z-0658-2019 Class II Terminated
FDA device recall Z-0658-2019 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on November 5, 2018 and is designated Class II. Reason for recall: Potential for external blood leaks from the dialyzer header The recall status is terminated (terminated April 17, 2023). Affected quantity: 9,097 cs x 12 units each.
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