FDA recall Z-0791-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF

Reason for recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Distribution

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Key facts

Status: Ongoing
Initiation date: 2024-11-21
Report date: 2025-01-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0791-2025