FDAFDA · Food and drugs·Recall number Z-1341-2013
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Published May 29, 2013 · Recall initiated: April 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Coloplast Manufacturing US, LLC
- Distributor
- Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
- Lot
- 3483171
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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