Device product
STERILE PVP, REF DYNDA1649
Z-0528-2024
Product summary
- Event
- Event 93395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 700 units
- Official record key
device-enforcement:Z-0528-2024
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 40889942326519 (case), 10889942326518 (each), Lot numbers: 2022060190, 2022021590
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.