Melker G47665Recalls & reported problems

Cook Incorporated · Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1785-2026 · Root cause: Incorrect or no expiration date · FDA record ↗

Device details

UDI-DI	`00827002476653`
Brand	Melker
Model	G47665
Catalog no.	C-TCCSB-500-UNI-01
Company	Cook Incorporated
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K160200
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 28, 2020

Device type (GMDN): Cricothyrotomy kit, single-use

A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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