FDA-Device2014-07-16Class II
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
RGI Medical Manufacturing, Inc.
Hazard
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Sold states
US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
Affected count
19,200 units.
Manufactured in
4637 NW 6th St, Gainesville, FL, United States
Products
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2014Don't want to check this manually?
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