Recall Z-0731-03 ยท CBL Absorbent, Carbon-Dioxide
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
| Date | Apr 17, 2003 (initiated Feb 11, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.