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

Hazard

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.

Details from the source

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. Quantity: 1450 units Lot/code info: 1) DYNDC3188: UDI/DI 10653160348825 (each) 00653160348828 (case), Lot Numbers: 2024040390, 2024051490, 2024070590, 2024100790.

UPC codes

10653160348825, 00653160348828

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.