Device Recall GOWN COOL IMPEV. XLGE BREATHABLE

  • Model / Serial
    Code:9002592 Lots: 140915320 exp. 9/30/19 150116795 exp. 3/31/16 150217395 exp. 3/31/16 150317646 exp. 3/31/16 150317849 exp. 5/31/16 150317850 exp. 5/31/16 150317848 exp. 5/31/16 150418378 exp. 6/30/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
  • Source
    USFDA