Events

Recall of Device Recall PALL Medical Breathing Circuit Filter

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

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
    68424
  • Event Risk Class
    Class 2
  • Event Number
    Z-2038-2014
  • Event Initiated Date
    2014-06-04
  • Event Date Posted
    2014-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127552
  • 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, bacterial, breathing-circuit - Product Code CAH
  • Reason
    Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
  • Action
    Urgent Product Recall Letters (dated 6/03/2014) and Response Forms were sent to customers via fax and e-mail starting on 6/04/14. The letters instruct the direct accounts to examine their inventory and place the affect lots on hold in quarantine. For questions, or if a patient injury associated with this device has been reported to you, please call Karen Peterson directly at 516.801.9267 (office) or 516.644.6171 (cell). The letter for the bulk product also instructs customers to notify their customers of the recall and advise them not use the affected lots if the product had been distributed.

Device

Device Recall PALL Medical Breathing Circuit Filter
  • Model / Serial
    REF BB50T: Lots 326902, 402802, 405002;  REF BB50T-BULK: Lots 228702, 229902, 328202
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
  • Product Description
    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. || The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.
  • Manufacturer
    Pall Corporation

Manufacturer

Pall Corporation
  • Manufacturer Address
    Pall Corporation, 25 Harbor Park Dr, Port Washington NY 11050-4605
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA