Date Initiated by Firm |
February 12, 2024 |
Date Posted |
March 19, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1307-2024 |
Recall Event ID |
94116 |
Product Classification |
Changer, tube, endotracheal - Product Code LNZ
|
Product |
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S |
Code Information |
UDI/GTIN: 00815277020008 each, 00810071639630 case
Lot Numbers:
ASM0038077
ASM0038129
ASM0038334
ASM0038598 |
Recalling Firm/ Manufacturer |
Sarnova HC, Llc 5000 Tuttle Crossing Blvd Dublin OH 43016-1534
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 in Commerce |
540 kits |
Distribution |
US Nationwide distribution.
|
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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