Medical device recalls Moderate risk

C.R. Bard, Inc. recalls Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent…

Recall date
July 7, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2387-2015
FDA classification
Class II
Brand / firm
C.R. Bard, Inc.
Sold / distributed
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.

Why it was recalled

Potential breach of the sterile barrier packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.

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