FDA-Device2013-03-13Class II
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Churchill Medical Systems, Inc.
Hazard
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
Sold states
Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
Affected count
2340
Manufactured in
87 Venture Drive, N/A, Dover, NH, United States
Products
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0914-2013Don't want to check this manually?
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