Recall of Device Recall Pall "TNA1" Total Nutrient Admixture Filter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pall Life Sciences Puerto Rico 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
    59174
  • Event Risk Class
    Class 2
  • Event Number
    Z-2715-2011
  • Event Initiated Date
    2011-06-15
  • Event Date Posted
    2011-06-30
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-01-10
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Filter, infusion line - Product Code FPB
  • Reason
    Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the tna1 filter used with total parenteral nutrition mixtures.
  • Action
    Pall Life Sciences LLC, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 15, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to maintain the product in quarantine. If distributed, the letter request that customers notify the user to discontinue use. Additionally, customers were asked to complete and return an attached Recall Response Form. The letter also included instructions on how to return the product. Please contact the Customer Service Department at 516-801-9923, if you have questions.

Device

  • Model / Serial
    Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.
  • Product Description
    Pall Total Nutrient Admixture Filter, 1.2 micron filter || This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Pall Life Sciences Puerto Rico Llc, Pall Blvd 99 & 100, Rd 194, Km 0.4, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
  • Source
    USFDA