Device product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Z-2135-2023
Product summary
- Event
- Event 92486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-2135-2023
Official wording
Reason: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Code information: UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268
Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.
Derived failure modes
-
Labeling or packaging
mislabeled