Z-0561-2011

Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet...

Name: Z-0561-2011 Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet...
Creator: Darex Container Products Div of W.R. Grace & Co.
Published: 2010-10-20
License: https://open.fda.gov/license/

Darex Container Products Div of W.R. Grace & Co. / initiated 2010-10-20 / Terminated / root cause: packaging

FDA source

Darex Container Products Div of W.R. Grace & Co. began a recall of 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... on 2010-10-20. The reason FDA records is "Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0561-2011
Status: Terminated
Initiated: 2010-10-20
Posted: 2010-12-08
Terminated: 2011-09-21
Recalling firm: Darex Container Products Div of W.R. Grace & Co.
Product: 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.
Product code: CBL Absorbent, Carbon-Dioxide
Reason for recall: Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 8,096 cartons
Distribution: Nationwide Distribution
Product codes and lots: 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 code CBL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)