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 & 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
- Recall number
- Z-0850-05
- 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 & 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
- Status
- Terminated
- Initiated
- 2005-03-31
- Posted
- 2005-05-25
- Terminated
- 2006-07-31
- Reason
- Both lots were found to be out of specification due to an elevated level of small particles (fines).
- Root cause
- Other
- 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.
- Quantity
- 360 PrePaks and 18 5-gallon pails
- Distribution
- California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
- Lot, serial or model codes
- pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006
- 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