Events

Recall of Device Recall SODASORB 48 IND H MED

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
    31687
  • Event Risk Class
    Class 2
  • Event Number
    Z-0850-05
  • Event Initiated Date
    2005-03-31
  • Event Date Posted
    2005-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38349
  • 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
    Both lots were found to be out of specification due to an elevated level of small particles (fines).
  • Action
    Recall letters dated 3/30/05 were sent to the accounts via DHL on 3/31/05, informing them that the two lots did not undergo final QC testing prior to shipment and do not meet finished product specifications. The accounts were requested to check their inventory for the affected lots, discontinue use and place it on hold pending return to W.R. Grace for replacement. Any questions were directed to the Sodasorb Recall Coordinator at 1-877-327-3987.

Device

Device Recall SODASORB 48 IND H MED
  • Model / Serial
    pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
  • Product Description
    Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails
  • 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 St, Chicago IL 60638-1405
  • Source
    USFDA