Device Recall VisuaLine Propoxyphene;

  • Model / Serial
    Sun Biomedical Part #: 15-2017, lot number: Vis-PPX Dip 07-094-1-85.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of NJ, TN, LA, GA, AZ, PA, NE, OH, ME, DE, VA, and CT.
  • Product Description
    VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sun Biomedical Laboratories, Inc., 1001 Lower Landing Rd, Blackwood NJ 08012-3124
  • Source
    USFDA