Z-0942-2021 Class II Terminated
FDA device recall Z-0942-2021 was initiated by Fresenius Medical Care Holdings, Inc. on December 17, 2020 and is designated Class II. Reason for recall: Bottles Missing Product Label The recall status is terminated (terminated January 5, 2023). Affected quantity: 2,280 cases (9,120 bottles).
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- January 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,280 cases (9,120 bottles)
Product Description
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Reason for Recall
Bottles Missing Product Label
Distribution Pattern
Nationwide
Code Information
Lot code: 20NTAC040