AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

FDA Recall #Z-1178-2025 — Class II — December 23, 2024

Recall #Z-1178-2025 Date: December 23, 2024 Classification: Class II Status: Ongoing

Product Description

AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

Reason for Recall

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Recalling Firm

Hollister Incorporated — Libertyville, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

701 box / 8,412 eaches

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UDI/DI 00610075095810, Lot Numbers: 4J162, 4J172, 4J182, 4L172, 4L182

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated