Device product
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Z-2131-2023
Product summary
- Event
- Event 92486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 183240 units
- Official record key
device-enforcement:Z-2131-2023
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: GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490
Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.
Derived failure modes
-
Labeling or packaging
mislabeled