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International Biophysics Corp. recalls IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM
Recalled August 26, 2015 · FDA recall Z-2423-2015 · International Biophysics
Hazard
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. · FDA Class II
Units
10,330 units
Sold at
Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Description
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Product
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
Manufacturer(s)
International Biophysics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →