Z-2946-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2024
- Initiation Date
- July 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product Description
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 for Recall
Due to packaging defects, sterility assurance and heparin activity may be compromised.
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.
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