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Recall Observatory FDA recall evidence

Device product

AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

Z-1179-2025

December 23, 2024

Class II

Product summary

Firm
Hollister Incorporated
Event
Event 96181
Status
Ongoing
Classification
Class II
Quantity
45 box / 540 eaches
Official record key
device-enforcement:Z-1179-2025

Official wording

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

Code information: UDI/DI 00610075095834, Lot Numbers: 4L172, 4L182

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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