Device Recall OPEN HEART TRAY

  • Model / Serial
    Code:9001393 Lots: 141116010 exp. 12/31/15 150217555 exp. 12/31/15 150217554 exp. 12/31/15 150418441 exp. 4/30/16 150418442 exp. 4/30/16 150518900 exp. 6/30/16
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    OPEN HEART TRAY 1/CS || 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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Code:9001196C Lots: 141015478 exp. 10/31/15 141115954 exp. 11/30/15 150318096 exp. 3/31/16 150418443 exp. 4/30/16 150418590 exp. 4/30/16 150518901 exp. 6/30/16
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    OPEN HEART TRAY 1/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • Model / Serial
    Code:900170 Lots: 141015613 exp. 10/31/15 141216317 exp. 1/31/16 150217278 exp. 3/31/16 150317688 exp. 3/31/16 150317689 exp. 4/30/16 141216317 exp. 1/31/16 150418269 exp. 4/30/16 150619236 exp. 6/30/16
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    OPEN HEART TRAY CUSTOMED 1/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer