FDA DeviceClass IINotable

FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmo

Date: 2026-05-27
Brand: Medtronic Perfusion Systems
Category: Medical Device
FDA Class: Class II

Description

Certain lots of product have the potential for a sterile barrier breach.

Hazard

Certain lots of product have the potential for a sterile barrier breach.

Remedy

3790 units

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