Endotracheal Tube Fastener Recalled for Decreased Skin Barrier Wear
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for an endotracheal tube fastener where decreased adhesion could lead to tube migration—a serious patient safety issue in airway management. However, the source reports no actual patient illnesses or injuries, only the potential risk. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Hollister Incorporated is recalling AnchorFast Oral Endotracheal Tube Fasteners, REF 9799. Approximately 30,527 boxes, containing 366,324 individual units, have been distributed worldwide to the United States and Canada.
The AnchorFast fastener is designed to secure endotracheal tubes in place during patient care. Hollister has received reports of decreased skin barrier wear time in these fasteners. This decreased wear time could lead to tube migration, where the tube moves from its intended position.
The affected product is identified by UDI/DI 00610075129386. Recalled lot numbers are: 4I192, 4I202, 4I212, 4I222, 4I232, 4I242, 4I252, 4I262, 4I272, 4I282, 4I292, 4I302, 4J012, 4J022, 4J032, 4J042, 4J052, 4J062, 4J072, 4J082, 4J092, 4J102, 4J112, 4J122, 4J132, 4J142, 4J152, 4J162, 4J212, 4J222, 4J232, 4J242, 4J252, 4J262, 4J272, 4J282, 4J292, 4J302, 4J312, 4K012, 4K022, 4K032, 4K042, 4K052, 4K062, 4K072, 4K082, 4K092, 4K102, 4K112, 4K122, 4K132, 4K142, 4K152, 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K242, 4K252, 4K262, 4K272, 4K282, 4K292, 4K302, 4L012, 4L022, 4L032, 4L042, 4L092, 4L112, 4L122, 4L132, 4L142, 4L152, 4L162, 4L172, 4L182.
The recalled product
- Product
- AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
- Manufacturer
- Hollister Incorporated
- Hazard
- adhesion-degradation
- tube-migration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00610075129386
- Lot Numbers: Lot
- 4I192
- 4I202
- 4I212
- 4I222
- 4I232
- 4I242
- 4I252
- 4I262
- 4I272
- 4I282
- 4I292
- 4I302
- 4J012
- 4J022
- 4J032
- 4J042
- 4J052
- 4J062
Distribution
Distributed nationwide across the United States.
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