Class II

Medical Device Recall: Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray

MEDLINE INDUSTRIES, LP - Northfield · November 18, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

250 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1042-2025

Status: ongoing

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