Data Foundry

Medical device recalls 2024

Curaplex Cricothyrotomy Field Kit with Instruments — Class II medical device recall Z-0721-2024

Ongoing recall by Sarnova HC, Llc, reported 2024-01-24, distributed nationwide. It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothy

Recall numberZ-0721-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSarnova HC, Llc, Dublin, OH, United States
Recall initiated2023-11-06
Classified2024-01-12
Reported by FDA2024-01-24
DistributedNationwide (US)
Quantity15 kits
Lot numbersASM0037685, ASM0037887
Model numbers351631I-A

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0721-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.