Events

Recall of Device Recall Sterile I.V. bag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instituto Grifols, S.A..

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
    34243
  • Event Risk Class
    Class 2
  • Event Number
    Z-0906-06
  • Event Initiated Date
    2005-11-29
  • Event Date Posted
    2006-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43324
  • 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
    Container, I.V. - Product Code KPE
  • Reason
    When the bags are filled with solution, they leak. the labeling process caused a hole to be formed in the bag.
  • Action
    The consignees were notified by phone beginning November 11, 2005. They were requested to return the unused product in exchange for bags from other lot numbers. The returned product will be quarantined at the warehouse. All Gri-bags from batch X-003 will be destroyed.

Device

Device Recall Sterile I.V. bag
  • Model / Serial
    FPB NEP, batch # X-003, code 722842.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to health care facilities in California, Georgia and Oregon.
  • Product Description
    Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. || Gri-bag 500 ml.
  • Manufacturer
    Instituto Grifols, S.A.

Manufacturer

Instituto Grifols, S.A.
  • Manufacturer Address
    Instituto Grifols, S.A., #2 Can Guasch Street,, Poligono Levante, Parets Del Valles, Barcelona CA Spain 90032-3520
  • Source
    USFDA