AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
FDA Recall #Z-1181-2025 — Class II — December 23, 2024
Product Description
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
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
4,955 box / 59,460 eaches
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated