NaturaLyte 2301 2K 3 — Class II medical device recall Z-1311-2022
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2022-07-13, distributed nationwide. The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the pa
| Recall number | Z-1311-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-01 |
| Reported by FDA | 2022-07-13 |
| Terminated | 2024-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 3 cases |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840861101702 |
| Lot numbers | 21AGAC009 |
| Model numbers | 08-2301-3 |
Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1311-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.