Recall Z-1181-2025
Hollister Incorporated · initiated December 23, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Codes / lots: UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
Reason for recall
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDA-determined 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.
Details
- Recall number
- Z-1181-2025
- Initiated
- December 23, 2024
- Posted by FDA
- February 19, 2025
- Product code
- CBH – Device, Fixation, Tracheal Tube
- Quantity
- 4,955 box / 59,460 eaches
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Hollister Incorporated, Libertyville, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1178-2025 Class II | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |
| Z-1179-2025 Class II | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |
| Z-1180-2025 Class II | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |