Events

Recall of Device Recall 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
    29184
  • Event Risk Class
    Class 2
  • Event Number
    Z-1231-04
  • Event Initiated Date
    2004-05-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33273
  • 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
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
  • Reason
    The suction regulator incorporates a gauge for the verification of suction levels. the particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
  • Action
    All direct accounts were contacted by the recalling firm''s Customer Service Representative to determine the location of the affected product. The CSR arrange for replacement proudct.

Device

Device Recall Suction Regulator
  • Model / Serial
    Regulator Model 7702L, Lot Number 04D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN,
  • Product Description
    Boheringer Suction Regulator Model 7702L, Lot number 04D || Boehinger Replacement Gauge, Model 9071, Lot number 200405.
  • Manufacturer
    Boehringer Laboratories Inc

Manufacturer

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