Z-1303-2022 Class II Terminated
FDA device recall Z-1303-2022 was initiated by Fresenius Medical Care Holdings, Inc. on May 4, 2022 and is designated Class II. 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. The recall status is terminated (terminated May 6, 2024). Affected quantity: 19 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1303-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026