FDAFDA · Food and drugs·Recall number Z-0794-2013
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Published February 13, 2013 · Recall initiated: January 8, 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
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Allergen Medical
- Distributor
- Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
- Lot
- Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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