Device product
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Z-1178-2025
Product summary
- Event
- Event 96181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 701 box / 8,412 eaches
- Official record key
device-enforcement:Z-1178-2025
Official wording
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Code information: UDI/DI 00610075095810, Lot Numbers: 4J162, 4J172, 4J182, 4L172, 4L182
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration