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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 64943
Product Type Devices
Status Ongoing
Recalling Firm Coloplast Manufacturing US, LLC
City Minneapolis
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. 3483171 Class II 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. 111 Z-1341-2013