FDA recall Z-1612-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B

Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Key facts

Status
Ongoing
Initiation date
2025-03-03
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2025