FDA-Device2013-05-29Class II
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Coloplast Manufacturing US, LLC
Hazard
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Sold states
Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Affected count
111
Manufactured in
1601 W River Rd, N/A, Minneapolis, MN, United States
Products
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1341-2013Don't want to check this manually?
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