Device Recall Genesis BPS, LLC

  • Model / Serial
    Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution & Switzerland
  • Product Description
    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe || Rx Only Genesis BPS, LLC || The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Genesis BPS, LLC., 65 Commerce Way, Hackensack NJ 07601-6302
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Cat #405-560BD Lot # 3650-23508; 3650-24116; 3650-24332; 3650-24399; 3650-24487; 3650-24519; 3650-23478; 3650-23971  Cat # 405-560MJ Lot #3630-23509; 3630-23972; 3630-24181; 3630-24333; 3630-24397; 3630-24488; 3630-24152
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution & Switzerland
  • Product Description
    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe || Rx Only Genesis BPS, LLC || The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
  • Manufacturer
  • Model / Serial
    Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution & Switzerland
  • Product Description
    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe || Rx Only Genesis BPS, LLC || The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
  • Manufacturer