FDA recall Z-0558-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

Reason for recall

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

Distribution

US Nationwide distribution in the state of NY.

Key facts

Status
Ongoing
Initiation date
2024-10-25
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0558-2025