Events

Recall of HACH SteriChek Residual Peroxide Reagent Strips

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

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
    51966
  • Event Risk Class
    Class 2
  • Event Number
    Z-2016-2009
  • Event Initiated Date
    2009-04-21
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81790
  • 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
    Dialyzer reprocessing system - Product Code LIF
  • Reason
    Some of the reagent strip bottles contain the incorrect strips.
  • Action
    Hach Company issued an "Urgent Medical Device Recall" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned. Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter. For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.

Device

HACH SteriChek Residual Peroxide Reagent Strips
  • Model / Serial
    Part Number: 811905, Lot Number: A8350; and Part Number: 1905LB, Lot Numbers: 8350 and 8345.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
  • Product Description
    HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. || SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
  • Manufacturer
    Hach Co

Manufacturer

Hach Co
  • Manufacturer Address
    Hach Co, 100 Dayton Ave, Ames IA 50010-6402
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA