Device product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Z-2136-2023
Product summary
- Event
- Event 92486
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1500 units
- Official record key
device-enforcement:Z-2136-2023
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: a) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528
Distribution pattern: Worldwide distribution - US Nationwide and the country of Panama.
Derived failure modes
-
Labeling or packaging
mislabeled