FDA Medical Device Recalls (openFDA)
Sarnova HC, Llc: Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
- Recall number
- Z-1307-2024
- Recalling firm
- Sarnova HC, Llc
- Product
- Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
- Status
- Open, Classified
- Initiated
- 2024-02-12
- Posted
- 2024-03-19
- Terminated
- not on file
- Reason
- Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
- Root cause
- Component design/selection
- Action
- Bound Tree issued URGENT NOTICE OF RECALL letters on February 12, 2024 via USPS Letter to Medical Inventory Controls/Supplies Coordinator/Buyer. Letter states reason for recall, health risk and actin to take: Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care at 800.533.0523 to arrange for a return of the product in exchange for a credit
- Quantity
- 540 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNZ
- Firm FEI
- 3014680755
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28