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U.S. Department of Health and Human Services

Class 2 Device Recall AnchorFast

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 Class 2 Device Recall AnchorFastsee related information
Date Initiated by FirmDecember 23, 2024
Date PostedFebruary 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1179-2025
Recall Event ID 96181
Product Classification Device, fixation, tracheal tube - Product Code CBH
ProductAnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Code Information UDI/DI 00610075095834, Lot Numbers: 4L172, 4L182
FEI Number 1480288
Recalling Firm/
Manufacturer		 Hollister Incorporated
2000 Hollister Dr
Libertyville IL 60048-3781
For Additional Information ContactChristine Ponka
224-358-5642
Manufacturer Reason
for Recall		Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDA Determined
Cause 2		Process change control
ActionHollister issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 12/23/2024 via FedEx and email. The notice explained the reason for the recall and potential risk and instructed customers to quarantine affected inventory, discard the product per their local procedures for product destruction, and Please complete and return the response form attached as soon as possible, even if you do not have affected product in your possession and send to ComplaintCommunication@Hollister.com. For product credit requests: If you are a direct customer of Hollister, contact Hollister Incorporated Customer Service for product credit at: 1-800-323-4060 (prompt #1). If you purchase product from a distributor, please contact your distributor for product credit. Hollister has posted this recall on their website with the link to the page.
Quantity in Commerce45 box / 540 eaches
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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