Device Recall BD SurePathTM Preservative Collection Vials

  • Model / Serial
    SurePath Collection Vial Replacement Cap, cat no. 490505 SurePath GYN Preservative Vial Kit, cat no. 490527 SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095 SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096 SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product
  • Product Description
    BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. || SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
  • Source
    USFDA