Food, drugs, devices › Fresenius Medical Care Holdings, Inc.
Device recall: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Fresenius Medical Care Holdings, Inc. (Waltham, MA) initiated this device recall on 1 Jun 2022; FDA lists 1 product record under event 90419, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 7 Oct 2024. Initiation: voluntary: firm initiated. Fresenius Medical Care Holdings, Inc. has 66 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fresenius Medical Care Holdings, Inc., Waltham, MA.
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."
Distribution
"US Nationwide distribution in the states of Texas and Louisiana."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1311-2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | 3 cases | Class II | Terminated | 13 Jul 2022 |
Context
Other enforcement events for Fresenius Medical Care Holdings, Inc.
All 66 events for Fresenius Medical Care Holdings, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of Texas and Louisiana."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Oct 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.