Events

Rappel de Device Recall Pall "TNA1" Total Nutrient Admixture Filter

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Pall Life Sciences Puerto Rico Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59174
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2715-2011
  • Date de mise en oeuvre de l'événement
    2011-06-15
  • Date de publication de l'événement
    2011-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101496
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Filter, infusion line - Product Code FPB
  • Cause
    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

Device Recall Pall "TNA1" Total Nutrient Admixture Filter
  • Modèle / numéro de série
    Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
    Pall Life Sciences Puerto Rico Llc

Manufacturer

Pall Life Sciences Puerto Rico Llc
  • Adresse du fabricant
    Pall Life Sciences Puerto Rico Llc, Pall Blvd 99 & 100, Rd 194, Km 0.4, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA