FDA Recall Terminated

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: Z-0731-03 · Initiated February 11, 2003

Recall

Recall Number
Z-0731-03
Event Number
25673
Firm
Darex Container Products Div of W.R. Grace & Co.
FEI Number
3003940942
Product Code
CBL
Status
Terminated
Root Cause
Other
Initiated
February 11, 2003
Posted
April 17, 2003
Terminated
January 26, 2004
Address
6050 W. 51st Street, Chicago, IL, 60639

Description

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

Reason

Contaminated with epoxy chips.

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.

Distribution

Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.

Quantity

32,232 pre-paks; 50,748 canister paks; 1,400 5-gallon pails; 49 55-gallon drums