FDAFDA · Food and drugs·Recall number Z-2945-2024
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB062901A BXB062902A BXB063901A BXB063902A BXB065901A BXB065902A BXB067901A BXB067902A BXB071501A BXB071502A BXB071901A BXB071902A BXB072901A BXB072902A BXB073901A BXB073902A BXB075901A BXB075902A BXB077901A BXB077902A BXB082901A BXB082902A BXB083901A BXB083902A BXB085901A BXB085902A BXB087901A BXB087902A BXBL082901A BXBL082902A BXBL083901A BXBL083902A BXBL085901A BXBL085902A BXBL087901A BXBL087902A BXB092901A BXB092902A BXB093901A BXB093902A BXB095901A BXB095902A BXB097901A BXB097902A Japan: BXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
Published September 11, 2024 · Recall initiated: July 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to packaging defects, sterility assurance and heparin activity may be compromised.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- W L Gore & Associates, Inc.
- Distributor
- 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.
- Lot
- 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 00733132658268 27713038 00733132658268 27713039 00733132658268 27713040 00733132658268 27713041 00733132658268 27713042 00733132658268 27713043 00733132658268 27713044 00733132658268 27713045 00733132658268 27713046 00733132658268 27713047 00733132658268 27713048 00733132658268 27713049 00733132658268 27713050 00733132658268 27713052 00733132658268 27713053 00733132658268 27713054 00733132658268 27713055 00733132658268 27713056 00733132658268 27713057 00733132658268 27713058 00733132658268 27713059 00733132658268 27713060 00733132658268 27713061 00733132658268 27713062 00733132658268 28047137 00733132658268 28047138 00733132658268 28047139 00733132658268 28161372 00733132658268 28161373 00733132658268 28161374 00733132658268 28161375 00733132658268 28161376 00733132658268 28161377 00733132658268 28161378 00733132658268 28161379 00733132658268 28161380 00733132658268 28212634 00733132658268 28212635 00733132658268 28212636 00733132658268 28212637 00733132658268 28212638 00733132658268 28212639 00733132658268 28212640 00733132658268 28212641 00733132658268 28212642 00733132658268 28212643 00733132658268 28356299 00733132658268 28356300 00733132658268 28356301 00733132658268 28356302 00733132658268 28356303 00733132658268 28356304 00733132658268 28378647 00733132658268 28378648 00733132658268 28378649 00733132658268 28378650 00733132658268 28378651 00733132658268 28390119 00733132658268 28390120 00733132658268 28390121 00733132658268 28390122 00733132658268 28390123 00733132658268 28431157 00733132658268 28431158 00733132658268 28431159 00733132658268 28431160 00733132658268 28431161 00733132658268 28532437 00733132658268 28532439 00733132658268 28532440 00733132658268 28540832 00733132658268 28540833 00733132658268 28540834 00733132658268 28540835 00733132658268 28540836 00733132658268 28547561 00733132658268 28547562 00733132658268 28547563 00733132658268 28564513 00733132658268 28564514 00733132658268 28564515 00733132658268 28696646 00733132658268 28696647 00733132658268 28696648 00733132658268 28696649 00733132658268 28696650 00733132658268 28696651 00733132658268 28696652 00733132658268 28696653 00733132658268 28696654 00733132658268 28696655 00733132658268 28696656 00733132658268 28696657 00733132658268 28696658 00733132658268 28696659 00733132658268 28696660 00733132658268 28696661 00733132658268 28696662 00733132658268 28696663 00733132658268 28696664 00733132658268 28696665 00733132658268 28696666 00733132658268 28696667 00733132658268 28696668 00733132
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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