Device product
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Z-1181-2025
Product summary
- Event
- Event 96181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,955 box / 59,460 eaches
- Official record key
device-enforcement:Z-1181-2025
Official wording
Reason: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Code information: UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
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