Z-1311-2022 Class II Terminated
FDA device recall Z-1311-2022 was initiated by Fresenius Medical Care Holdings, Inc. on Jun 1, 2022 and is designated Class II. 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… The recall status is terminated (terminated Oct 7, 2024). Affected quantity: 3 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 13, 2022
- Initiation Date
- Jun 1, 2022
- Termination Date
- Oct 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 cases
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of Texas and Louisiana.
Code Information
UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1311-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026