Summary
The FDA issued a Class II for AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, by Hollister Incorporated. Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration.
Details
Source
Device Recall
External ID
Z-1181-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Lot/Code Info: UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
Quantity Affected: 4,955 box / 59,460 eaches
Reason for Recall
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-23
Company
Libertyville, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hollister Incorporated has 10 FDA actions in our database, including 4 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hollister Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hollister Incorporated have FDA actions?
Hollister Incorporated has 10 FDA actions in our database, including 4 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1181-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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