Device product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Z-2132-2023
Product summary
- Event
- Event 92486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-2132-2023
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) 10195327303969, UDI/DI (CS) 40195327303960; Lot Numbers: 23EBE453, 23CBW365
Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.
Derived failure modes
-
Labeling or packaging
mislabeled