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U.S. Department of Health and Human Services

Class 2 Device Recall Curaplex Nasal Intubation Kit

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  Class 2 Device Recall Curaplex Nasal Intubation Kit see related information
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
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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