FDA Medical Device Recalls (openFDA)
Darex Container Products Div of W.R. Grace & Co.: 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 & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton), canister paks (pre-measured 2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label distributed by Sims Portex Inc., Keene, NH 03431
- Recall number
- Z-0731-03
- Recalling firm
- Darex Container Products Div of W.R. Grace & Co.
- Product
- 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 & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton), canister paks (pre-measured 2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label distributed by Sims Portex Inc., Keene, NH 03431
- Status
- Terminated
- Initiated
- 2003-02-11
- Posted
- 2003-04-17
- Terminated
- 2004-01-26
- Reason
- Contaminated with epoxy chips.
- Root cause
- Other
- 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.
- Quantity
- 32,232 pre-paks; 50,748 canister paks; 1,400 5-gallon pails; 49 55-gallon drums
- Distribution
- Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.
- Lot, serial or model codes
- Lot numbers CN12-P115-02, CN12-P115-03, CN12-P115-04, CN12-P115-05, CN12-P115-07, CN12-P115-08, CN12-P115-09, CN12-P115-10, CN12-P115-11, CN12-P115-12, CN12-P115-13, CN12-P115-14, CP01-P115-01, CP01-P115-02, CP01-P115-03, CP01-P115-04, CP01-P115-05, CP01-P115-08, CP01-P115-10, CP01-P115-11, CP01-P115-12, CP01-P115-15, CP01-P115-16, CP01-P115-17, CP01-P115-18, CP01-P115-19, CP01-P115-20, CP01-P115-21, CP01-P115-22 and CP01-P115-23.
- 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