FDA DeviceClass IINotable

FDA Recall: Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Cathete

Date: 2026-06-17
Brand: Mozarc Medical US LLC
Category: Medical Device
FDA Class: Class II

Description

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

Hazard

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

Remedy

25627

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