Endotracheal Tube Fastener Recalled for Potential Tube Migration Risk
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
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 an FDA Class II recall of a medical device without reported injuries, hospitalizations, or deaths. The hazard presents a risk of patient harm but is theoretical—no illnesses or injuries have been reported in the source text, meeting the criterion for a High (3) severity classification.
Plain-English summary
Hollister Incorporated is recalling AnchorFast SlimFit oral endotracheal tube fasteners (REF 9787) distributed worldwide, including the United States and Canada. The fasteners are used to secure endotracheal tubes during patient intubation.
The recall was initiated due to decreased skin barrier wear time of the fastener, which could lead to tube migration. A tube that migrates from its correct position may compromise patient airway management.
Affected units include lot numbers 4L172 and 4L182. Healthcare facilities and providers who have received these products should discontinue use and contact Hollister for replacement units. Patients currently using affected fasteners should consult with their healthcare provider.
The recalled product
- Product
- AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
- Manufacturer
- Hollister Incorporated
- Hazard
- tube-migration
- skin-barrier-wear
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 (3)
- UDI/DI 00610075095834
- Lot Numbers: 4L172
- 4L182
Distribution
Distributed nationwide across the United States.
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