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RGI Medical Manufacturing, Inc. recalls Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressu
Recalled July 16, 2014 · FDA recall Z-1996-2014 · RGI Medical Manufacturing
Hazard
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. · FDA Class II
Units
19,200 units.
Sold at
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.
Description
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Product
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Manufacturer(s)
RGI Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →