FDA Device recall Z-1370-2022
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r…
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r… by Fresenius Medical Care Holdings, citing alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1370-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-31 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | n/a |
Product
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Reason
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Identifiers
| code_info | UDI-DI: (01) 000840861101696 (17) 240331 (10) 22CTAC106 Lot Number: 22CTAC106 Exp Date: 2024-03-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1370-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.