MEDLINE INDUSTRIES, LP - Northfield: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB

Hazard

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Details from the source

Reason for recall: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". Distribution: Worldwide distribution - US Nationwide and the country of Panama. Quantity: 1500 units Lot/code info: 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

UPC codes

10195327112554, 40195327112555, 10195327267149, 40195327267149

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.