Z-1303-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- May 4, 2022
- Termination Date
- May 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 cases
Product Description
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Reason for Recall
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Distribution Pattern
US Nationwide distribution in the state of Pennsylvania.
Code Information
UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017