FDA Device recall Z-1311-2022
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
- FDA Device
- Class II
- terminated
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 by Fresenius Medical Care Holdings, citing the product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1311-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-01 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Reason
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
Identifiers
| code_info | UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2022%22
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