Events

Recall of Device Recall Genesis BPS, LLC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genesis BPS, LLC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68874
  • Event Risk Class
    Class 2
  • Event Number
    Z-2667-2014
  • Event Initiated Date
    2014-07-17
  • Event Date Posted
    2014-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128912
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, blood transfusion - Product Code BRZ
  • Reason
    Genesis bps is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
  • Action
    Genesis BPS sent an Urgent Medical Device Recall letter with a Recall Letter/Confirmation Form on July 17, 2014 to all affected customers. Customers were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if there is further distribution of the product, customers should be identified and be notified of the recall. Product use should be discontinued and disposed of according to applicable federal regulations and internal protocols. The attached confirmation form should be completed and returned to Genesis by either fax or (201) 708-1104 or e-mail (info@genesisbps.com). Questions can be directed to (201) 708-1400 ext 2004 (9:00 and to 5:00 pm EST). For questions regarding this recall call 201-488-1174.

Device

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
    General Hospital and Personal Use Devices
  • 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
    Genesis BPS, LLC.

Manufacturer

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