medical Class II Updated 2025-02-05

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) CENTRAL LINE DRESSI

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) DYNDC3188: UDI/DI 10653160348818 (each) 00653160348811 (case), Lot Numbers: 2024030690, 2024041990, 2024082390.
View official government recall

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