FDA-Device2015-08-26Class II

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

C.R. Bard, Inc.
Hazard

Potential breach of the sterile barrier packaging.

Sold states
Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
Affected count
534,972 each
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2388-2015

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