FDA-Device2023-07-19Class II
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Sold states
Worldwide distribution - US Nationwide and the country of Panama.
Affected count
1500 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2023Don't want to check this manually?
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