FDA recall Z-1713-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K

Reason for recall

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

Key facts

Status: Ongoing
Initiation date: 2025-03-19
Report date: 2025-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2025