FDA-Device2014-11-05Class II
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Coloplast Manufacturing US, LLC
Hazard
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Sold states
Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.
Affected count
217,540
Manufactured in
1601 W River Rd, N/A, Minneapolis, MN, United States
Products
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2015Don't want to check this manually?
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