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.

Reason: Due to packaging defects, sterility assurance and heparin activity may be compromised.

Code information: Lot Serial Number/UDI: 27342032/00733132658053; 27342035/00733132658053; 27342038/00733132658053; 27342047/00733132657926; 27342078/00733132657940; 27342079/00733132657940; 27342102/00733132657957; 27342104/00733132657957; 27342108/00733132657957; 27342253/00733132657964; 27342255/00733132657964; 27342256/00733132657964; 27342257/00733132657964; 27342258/00733132657964; 27342259/00733132657964; 27342260/00733132657964; 27342261/00733132657964; 27342262/00733132657964; 27342263/00733132657964; 27342264/00733132657971; 27342266/00733132657971; 27342267/00733132657971; 27342268/00733132657971; 27342269/00733132657971; 27342270/00733132657971; 27342290/00733132657988; 27342333/00733132657995; 27342334/00733132657995; 27342335/00733132657995; 27342336/00733132657995; 27342337/00733132657995; 27342338/00733132657995; 27342339/00733132657995; 27342340/00733132657995; 27342341/00733132657995; 27342342/00733132657995; 27342343/00733132657995; 27342344/00733132657995; 27342345/00733132657995; 27342346/00733132657995; 27342347/00733132657995; 27342349/00733132657995; 27342350/00733132657995; 27342352/00733132657995; 27342403/00733132658008; 27342535/00733132658015; 27342536/00733132658015; 27342571/00733132658022; 27342572/00733132658022; 27342585/00733132658039; 27342586/00733132658039; 27342587/00733132658039; 27342591/00733132658039; 27342624/00733132658046; 27342626/00733132658046; 27342627/00733132658046; 27342628/00733132658046; 27399807/00733132658053; 27399808/00733132658053; 27399814/00733132658053; 27399815/00733132658053; 27399816/00733132658053; 27399883/00733132657957; 27399884/00733132657957; 27399886/00733132657957; 27399894/00733132657964; 27399895/00733132657964; 27399896/00733132657964; 27399897/00733132657964; 27399898/00733132657964; 27399920/00733132657971; 27399921/00733132657971; 27399922/00733132657971; 27399923/00733132657971; 27399924/00733132657971; 27399925/00733132657971; 27399929/00733132657988; 27399933/00733132657988; 27399934/00733132657988; 27399935/00733132657988; 27399936/00733132657988; 27399937/00733132657988; 27399938/00733132657988; 27399939/00733132657988; 27399942/00733132657988; 27400054/00733132658015 27400056/ 00733132658015 27400073/ 00733132658022 27400077/ 00733132658039 27400078/ 00733132658039 27400079/ 00733132658039 27400084/ 00733132658039 27400085/ 00733132658039 27400103/ 00733132658046 27400104/ 00733132658046 27400105/ 00733132658046 27400110/ 00733132658046 27400111/ 00733132658046 27461768/ 00733132658046 27461769/ 00733132658046

Distribution pattern: 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.