Device product
STERILE PVP SOLUTION, REF DYNDA1907
Z-0525-2024
Product summary
- Event
- Event 93395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8250 units
- Official record key
device-enforcement:Z-0525-2024
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 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405
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.