FDA recall Z-2593-2025

Medline Industries, LP · Class I · device

Product

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Reason for recall

Convenience kits labeled as sterile have not gone through the sterilization process.

Distribution

US Distribution to States of: FL, MD, NJ, TN

Key facts

Status: Ongoing
Initiation date: 2025-08-08
Report date: 2025-10-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2593-2025