Z-1371-2022 Class II Ongoing
FDA device recall Z-1371-2022 was initiated by Fresenius Medical Care Holdings, Inc. on May 31, 2022 and is designated Class II. Reason for recall: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use The recall status is ongoing. Affected quantity: 163 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2022
- Initiation Date
- May 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 cases
Product Description
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Reason for Recall
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Distribution Pattern
Natiowide
Code Information
UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1371-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026