FDA-Device2018-04-11Class II

Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

C.R. Bard, Inc.
Hazard

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Sold states
US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
Affected count
10,949,013 units in total
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2018

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