Events

Recall of Device Recall SODASORB 48 IND HP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Darex Container Products Div of W.R. Grace & 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
    25673
  • Event Risk Class
    Class 2
  • Event Number
    Z-0730-03
  • Event Initiated Date
    2003-02-11
  • Event Date Posted
    2003-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26317
  • 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
    Absorbent, Carbon-Dioxide - Product Code CBL
  • Reason
    Contaminated with epoxy chips.
  • Action
    Recalled by letter dated 2/11/03 on W.R. Grace-Conn. letterhead. The accounts were informed that the product was contaminated with trace amounts of material from their processing equipment, which posed no hazard to health. The accounts were requested to return all unopened packages of Sodasorb with the affected lot numbers for replacement.

Device

Device Recall SODASORB 48 IND HP
  • Model / Serial
    Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.
  • Product Description
    High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in 5-gallon pails under the W.R. Grace label
  • Manufacturer
    Darex Container Products Div of W.R. Grace & Co.

Manufacturer

Darex Container Products Div of W.R. Grace & Co.
  • Manufacturer Address
    Darex Container Products Div of W.R. Grace & Co., 6050 W. 51st Street, Chicago IL 60639
  • Source
    USFDA