Devices

Device Recall UNIVERSAL PACK

  • Model / Serial
    Code:9001587 Lots: 141115774 exp. 11/30/15 141115774 exp. 11/30/15 150116694 exp. 2/28/16 150217474 exp. 2/28/16 150317624 exp. 5/31/16 150418305 exp. 5/31/16 150518651 exp. 5/31/16
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Only in Puerto Rico.
  • Product Description
    UNIVERSAL PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall Universal Pack
  • Model / Serial
    Lot number and expiration date  87597, 2/28/2017 88967, 4/30/2017
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • Product Description
    Universal Pack, part number AMS2036
  • Manufacturer
    Windstone Medical Packaging, Inc.