FDA-Device2015-04-29Class II

7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

Churchill Medical Systems, Inc.
Hazard

Potential for leaking caused by insufficient bond between needleless device and female luer.

Sold states
Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
Affected count
129,500
Manufactured in
87 Venture Drive, Dover, NH, United States
Products
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2015

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