FDA-Device2020-06-10Class II
Pressure Monitoring Tray, C-PMSY, G02854
Cook Inc.
Hazard
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Sold states
Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia
Affected count
1899
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Pressure Monitoring Tray, C-PMSY, G02854
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2204-2020Don't want to check this manually?
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