FDA recall Z-1041-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

Reason for recall

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-11-18
Report date
2025-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2025