FDA Medical Device Recalls (openFDA)
Darex Container Products Div of W.R. Grace & Co.: 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.
- Recall number
- Z-0561-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-10-20
- Posted
- 2010-12-08
- Terminated
- 2011-09-21
- Reason
- 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
- 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
- 8,096 cartons
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBL
- Firm FEI
- 3003940942
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28