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Open, Classified

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.

FDA Recall Z-0721-2024 · Posted 2024-01-12

Recalling FirmSarnova HC, Llc
Recall StatusOpen, Classified
Product CodeCAE
Date Initiated2023-11-06
Product Quantity15 kits

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.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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