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W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX
Recalled September 11, 2024 · FDA recall Z-2946-2024 · W L Gore & Associates
Hazard
Due to packaging defects, sterility assurance and heparin activity may be compromised. · FDA Class II
Units
100 units
Sold at
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
Description
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
Manufacturer(s)
W L Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →