Events

Recall of Device Recall May and Grunwald's Stain

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EMD Chemicals 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
    39354
  • Event Risk Class
    Class 3
  • Event Number
    Z-0133-2008
  • Event Initiated Date
    2007-07-30
  • Event Date Posted
    2007-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55274
  • 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
    Hematology Stains - Product Code KQC
  • Reason
    Out of spec -- the batch (lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
  • Action
    EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.

Device

Device Recall May and Grunwald's Stain
  • Model / Serial
    Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was released to 2 distributors; one in the US, one in Canada
  • Product Description
    Harleco || May and Grunwald's Stain; || 0.17% w/v; || Methanol Solution UN1230; || EMD Chemicals Inc. || An Affilifate of Merck KGaA || Damstadt, Germany; || 480 South Democrat Road; || Gibbstown, NJ 08027; || 1 liter and 4 liter poly bottles
  • Manufacturer
    EMD Chemicals Inc

Manufacturer

EMD Chemicals Inc
  • Manufacturer Address
    EMD Chemicals Inc, 480 S Democrat Rd, Gibbstown NJ 08027-1239
  • Source
    USFDA