FDA DeviceClass IINotable

FDA Recall: Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP

Date: 2026-04-29
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Remedy

19189 units

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