The Recall Desk

FDA (Devices) recall action 93665

Sarnova HC, Llc recalled 2 products on 2024-01-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-01-24
Critical
0
Units
1,078

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2024-01-24

    Curaplex Cricothyrotomy Field Kit Recalled for Incompatible Tube Holder

    Sarnova HC recalls 15 Curaplex Cricothyrotomy Field Kits nationwide due to an incompatible endotracheal tube holder that prevents proper tube securement during cricothyrotomy procedures.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-01-24

    Field Cricothyrotomy Kit Recalled for Incompatible Endotracheal Tube Holder

    Sarnova HC is recalling the Curaplex Field Cric Kit due to an incompatible endotracheal tube holder that prevents practitioners from securing the tube during cricothyrotomy procedures. The recall affects 1,063 kits distributed nationwide.

    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.
    Category
    Distribution
    0 states