FDA recall Z-0636-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B

Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-10-09
Report date: 2024-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2025