Recall Z-1180-2025 ยท CBH Device, Fixation, Tracheal Tube
Hollister Incorporated
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
| Date | Feb 19, 2025 (initiated Dec 23, 2024) |
| Status | Open, Classified |
| Reason | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| Root cause | Process change control |
| Action | 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 Incorpora |
| Quantity | 30,527 box / 366,324 eaches |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.