Device product
STERILE POVIDONE, REF DYNDA2061
Z-0531-2024
Product summary
- Event
- Event 93395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-0531-2024
Official wording
Reason: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Code information: UDI/DI 40889942697633 (case), 10889942697632 (each), Lot numbers: 2022040790, 2022062190
Distribution pattern: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Derived failure modes
-
Unknown
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.