Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- April 12, 2013
- Posted
- May 20, 2013
- Terminated
- January 21, 2014
- Recall Number
- Z-1341-2013
- Quantity
- 111
- Firm Location
- Minneapolis, MN
Reason for Recall
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.
Distribution
Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Lot / Code Info
3483171
Root Cause
Labeling mix-ups
Action Taken
Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992.
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