Events

Recall of SODASORB LF PrePaks

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
    57064
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-2011
  • Event Initiated Date
    2010-10-20
  • Event Date Posted
    2010-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95503
  • 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, cargon dioxide - Product Code CBL
  • Reason
    Pre-pak units of sodasorb co2 absorbent manufactured prior to august 2010 may have missing or illegible expiration dates and/or batch numbers.
  • Action
    Darex/W.R. Grace sent a Customer Notification to their sole direct account of the recall and the account provided Darex/W.R. Grace with lists of their customers who received the recalled products. Darex then sent undated recall letters to those accounts on 10/20-22/10. The accounts were informed of the product, the problem, and the action that should be taken. The accounts were warned not to use Pre-Pak units with missing or illegible expiration dates and/or batch numbers and were requested to examine their inventories of Pre-Pak units, placing all units that had missing or illegible expiration dates and/or batch numbers on hold for destruction and replacement. The accounts were instructed to call W.R. Grace at 1-800-492-7632 to arrange for replacement. The accounts were also requested to complete and return the reply postcard, indicating how much product was destroyed.

Device

SODASORB LF PrePaks
  • Model / Serial
    Batch Numbers: CX01-P128-04, CX01-P128-08, CX02-P128-04, CX02-P128-05, CX02-P128-08, CX06-P128-02, CX07-P128-01, CX07-P128-02, CX12-P128-03, CX12-P128-04, CX12-P128-05, CX12-P128-07, CZ03-P128-09, CZ07-P128-01, CZ07-P128-01, CZ07-P128-10 and CZ07-P128-11.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted or upon moisture loss; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton || Sodasorb LF is used for absorption of carbon dioxide in low flow anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, desflurane, sevoflurane and isoflurane.
  • 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