Events

Recall of Boehringer Suction Regulator

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

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
    32810
  • Event Risk Class
    Class 2
  • Event Number
    Z-0155-06
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2005-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40856
  • 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
    Regulator, Vacuum - Product Code KDP
  • Reason
    Condition exists that prevents complete shutoff of the valve.
  • Action
    The recalling firm telephoned their customers on 7/25/05 to inform them of the problem, request the return of the recalled product, and inform them that replacement products were being shipped

Device

Boehringer Suction Regulator
  • Model / Serial
    Lot numbers 05F and 05G
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to hospitals AZ, AK, CA, FL, LA, MI, MO, NC, NJ, OR, PA, SC, UT, VA, and WA.
  • Product Description
    Boehringer Suction Regulator Model number 3704
  • Manufacturer
    Boehringer Laboratories, Inc.

Manufacturer

Boehringer Laboratories, Inc.
  • Manufacturer Address
    Boehringer Laboratories, Inc., 500 E Washington St, Norristown PA 19401-5149
  • Source
    USFDA