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Allergen Medical recalls SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedure
Recalled February 13, 2013 · FDA recall Z-0794-2013 · Allergen Medical
Hazard
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured · FDA Class II
Units
225 units (US) and 81 (Outside US)
Sold at
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.
Description
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Product
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Manufacturer(s)
Allergen Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →