FDA recall Z-2136-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2023-05-18
Report date
2023-07-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2023