FDA-Device2019-12-04Class II

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Hazard

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

Sold states
One Customer Located in TN
Affected count
75
Manufactured in
87 Venture Dr, Dover, NH, United States
Products
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0585-2020

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