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U.S. Department of Health and Human Services

Class 2 Device Recall Curaplex Field Cric Kit

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  Class 2 Device Recall Curaplex Field Cric Kit see related information
Date Initiated by Firm November 06, 2023
Date Posted January 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-0720-2024
Recall Event ID 93665
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Code Information Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197
Recalling Firm/
Manufacturer		 Sarnova HC, Llc
5000 Tuttle Crossing Blvd
Dublin OH 43016-1534
For Additional Information Contact BTM Customer Care
800-533-0523
Manufacturer Reason
for Recall		 It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action An URGENT: MEDICAL DEVICE RECALL notification letter dated 11/6/23 was sent to customers. Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care to arrange for a return of the product in exchange for a credit.
Quantity in Commerce 1063 kits
Distribution US Nationwide
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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