Device product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Z-1311-2022
Product summary
- Event
- Event 90419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases
- Official record key
device-enforcement:Z-1311-2022
Official wording
Reason: 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.
Code information: UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Distribution pattern: US Nationwide distribution in the states of Texas and Louisiana.
Derived failure modes
-
Unknown
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.