Date Initiated by Firm |
November 06, 2023 |
Date Posted |
January 12, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0721-2024 |
Recall Event ID |
93665 |
Product Classification |
Airway, oropharyngeal, anesthesiology - Product Code CAE
|
Product |
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy. |
Code Information |
Lot Numbers: ASM0037685
ASM0037887 |
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 |
15 kits |
Distribution |
US Nationwide |
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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