Events

Recall of Device Recall Keeler All Pupil II Indirect Ophthalmoscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Keeler Instruments 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
    46741
  • Event Risk Class
    Class 2
  • Event Number
    Z-1132-2008
  • Event Initiated Date
    2008-01-08
  • Event Date Posted
    2008-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68117
  • 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
    Ophthalmoscope - Product Code HLI
  • Reason
    Good manufacturing practices (gmp) deficiencies may compromise the safety and effectiveness of the device. firm is on import alert 89-04 and released product.
  • Action
    Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.

Device

Device Recall Keeler All Pupil II Indirect Ophthalmoscope
  • Model / Serial
    Serial numbers: 86249, 85806, 85598, 85601, 86390, 67321, 85600, 85697, 86372, 86394, 85599, 85602, 66378, 85814, 86392, 85605, 66886, 66708, 86255, 85565, 85556, 85558, 85562, 86370, and 66882.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to a distributor in NJ.
  • Product Description
    Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
  • Manufacturer
    Keeler Instruments Inc

Manufacturer

Keeler Instruments Inc
  • Manufacturer Address
    Keeler Instruments Inc, 456 Parkway, Broomall PA 19008
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    USFDA