AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
Hollister Incorporated · Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Open FDA's page for this record- Cfres ID
- 212268
- Product res number
- Z-1181-2025
- Event date initiated
- 2024-12-23
- Event date posted
- 2025-02-19
- Recall status
- Open, Classified
- Res event number
- 96181
- Product code
- CBH
- Product description
- AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
- Code info
- UDI/DI 00610075186518, Lot Numbers: 4K162, 4K172, 4K182, 4K192, 4K202, 4K212, 4K222, 4K232, 4K252, 4K262, 4L012, 4L022, 4L032, 4L042, 4L052, 4L132.
- Firm FEI number
- 1480288
- Recalling firm
- Hollister Incorporated
- Address 1
- 2000 Hollister Dr
- City
- Libertyville
- State
- IL
- Postal code
- 60048-3781
- Additional info contact
- Christine Ponka 224-358-5642
- Reason for recall
- Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Root cause description
- Process change control
- Product quantity
- 4,955 box / 59,460 eaches
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- 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 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.
- Harmonized identifiers (openFDA)
- Device name
- Device, Fixation, Tracheal Tube
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5770
- Device class
- 1
- K number
- K822794, K903539, K882079, K864526, K862084, K811185, K922657, K882694, K860845, K882891, K843790, K872832, K830706, K900912, K936094, K802601, K942529, K810737, K904974, K942395, K781695, K872277, K940448, K941384, K900787, K950318, K934288, K933781, K912884, K851874, K871560, K935171, K942016, K902604, K902065, K905231, K900236, K964399, K921698, K950930 +7 more
- Registration number
- 1214422, 3003965134, 3015416207, 3013298431, 3021234365, 9611024, 3015058854, 3006113262, 8010939, 8040412, 1061124, 9616567, 1314417, 3013550220, 3006755899, 8021995, 3016112560, 3011600579, 3011137372, 3006157842, 1526863, 3003902312, 3013412170, 3006563173, 3004727093, 3010834934, 3034669683, 3013735622, 3007483335, 1647162, 3026036971, 3016171961, 1921846, 3008311916, 8010485, 3014146451, 3010131137, 2025816, 1417592, 3045058049 +107 more
- FEI number
- 3003361161, 1214422, 3003965134, 3015416207, 3013298431, 3021234365, 3015058854, 3006113262, 3002807170, 1000306115, 1314417, 3013550220, 3005304066, 3002806816, 3006755899, 3016112560, 3011600579, 3006157842, 3001236905, 1526863, 3003902312, 3013412170, 1000125536, 3006563173, 3010834934, 3004727093, 3034669683, 3013735622, 3007483335, 3026036971, 3016171961, 1921846, 3008311916, 3014146451, 3010131137, 2025816, 1417592, 3045058049, 1220850, 3011248163 +107 more