AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
This recall is currently active, issued February 19, 2025. It was issued by Hollister Incorporated.
- Company
- Hollister Incorporated
- Recall Initiated
- December 23, 2024
- Posted
- February 19, 2025
- Recall Number
- Z-1180-2025
- Quantity
- 30,527 box / 366,324 eaches
- Firm Location
- Libertyville, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Info
UDI/DI 00610075129386, Lot Numbers: Lot, 4I192, 4I202, 4I212, 4I222, 4I232, 4I242, 4I252, 4I262, 4I272, 4I282, 4I292, 4I302, 4J012, 4J022, 4J032, 4J042, 4J052, 4J062, 4J072, 4J082, 4J092, 4J102, 4J112, 4J122, 4J132, 4J142, 4J152, 4J162, 4J212, 4J222, 4J232, 4J242, 4J252, 4J262, 4J272, 4J282, 4J292, 4J302, 4J312, 4K012, 4K022, 4K032, 4K042, 4K052, 4K062, 4K072, 4K082, 4K092, 4K102, 4K112, 4K122, 4K132, 4K142, 4K152, 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K242, 4K252, 4K262, 4K272, 4K282, 4K292, 4K302, 4L012, 4L022, 4L032, 4L042, 4L092, 4L112, 4L122, 4L132, 4L142, 4L152, 4L162, 4L172, 4L182.
Root Cause
Process change control
Action Taken
Hollister 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.