Device product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Z-2134-2023
Product summary
- Event
- Event 92486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-2134-2023
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)10195327286057, UDI/DI(CS) (01)40195327286058; Lot Numbers: 23EDA775, 23CDB962
Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.
Derived failure modes
-
Labeling or packaging
mislabeled