Device product
PVP SOLUTION SING STRL, REF DYNDA1858
Z-0529-2024
Product summary
- Event
- Event 93395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1950 units
- Official record key
device-enforcement:Z-0529-2024
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 40889942539858 (case), 10889942539857 (each), Lot numbers: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, 2021092190
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.