Z-1180-2025 Class II Ongoing
FDA device recall Z-1180-2025 was initiated by Hollister Incorporated on December 23, 2024 and is designated Class II. Reason for recall: Hollister received reports of decreased skin barrier wear time which could can lead to tube migration The recall status is ongoing. Affected quantity: 30,527 box / 366,324 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2025
- Initiation Date
- December 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,527 box / 366,324 eaches
Product Description
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Reason for Recall
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
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.