Device Recall BioStable 5F SL55CM IR145 Kit

  • Model / Serial
    UPN: H965458820; Lot: 5301752
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
  • Product Description
    Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    UPN: H965458180; Lot: 5303175, 5305572
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
  • Product Description
    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
  • Manufacturer
  • Model / Serial
    UPN: H965458860; Lot: 5303442
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
  • Product Description
    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
  • Manufacturer