W L Gore & Associates, Inc.: Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BX

Hazard

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

Details from the source

Reason for recall: Due to packaging defects, sterility assurance and heparin activity may be compromised. Distribution: 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. Quantity: 42,901 units Lot/code info: Lot Serial Number/UDI: 27884430 00733132658251 27884431 00733132658251 27884432 00733132658251 27884433 00733132658251 27884434 00733132658251 27884435 00733132658251 27884436 00733132658251 27884437 00733132658251 27884438 00733132658251 27884439 00733132658251 27884440 00733132658251 27884441 00733132658251 27884442 00733132658251 27884443 00733132658251 27884444 00733132658251 27884445 00733132658251 28325852 00733132658251 28325853 00733132658251 28325854 00733132658251 28325856 00733132658251 28325857 00733132658251 28431071 00733132658251 28431072 00733132658251 28431073 00733132658251 28547558 00733132658251 28547559 00733132658251 28547560 00733132658251 28691206 00733132658251 28691207 00733132658251 28691208 00733132658251 28691209 00733132658251 28928606 00733132658251 28928607 00733132658251 28928608 00733132658251 28928609 00733132658251 28928610 00733132658251 28928611 00733132658251 28928612 00733132658251 28928613 00733132658251 28961589 00733132658251 28961590 00733132658251 28961591 00733132658251 29039475 00733132658251 29039476 00733132658251 29039477 00733132658251 29039478 00733132658251 29039479 00733132658251 28356298 00733132658268 27713024 00733132658268 27713025 00733132658268 27713026 00733132658268 27713027 00733132658268 27713028 00733132658268 27713029 00733132658268 27713030 00733132658268 27713031 00733132658268 27713032 00733132658268 27713033 00733132658268 27713034 00733132658268 27713035 00733132658268 27713036 00733132658268 27713037 0073

UPC codes

00733132658251, 00733132658268, 00733132658275, 00733132658282, 00733132658299, 00733132658305

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.