Device Recall COSEAL Surgical Sealant

  • Model / Serial
    HA160136
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • Product Description
    COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp, 21026 Alexander Ct, Hayward CA 94545-1234
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    HA160151, HA151205, HA151036, HA151035, HA160229
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • Product Description
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
  • Model / Serial
    HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • Product Description
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
  • Model / Serial
    Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Coseal Surgical Sealant. || Coseal is an adjunctive surgical sealant.
  • Manufacturer
  • Model / Serial
    Lot Numbers: HA080828, HA080841, HA081101, HA081216,  HA081217, HA090113, HA090225, HA090226, & HA090427.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. || Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
  • Manufacturer
  • Model / Serial
    Lot Numbers: HA080942, HA080943, HA081001E, HA081046E, HA081102, HA081132, HA081235, HA090139, HA090241, & HA090342.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. || Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
  • Manufacturer
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