Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0731-03

Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which...

Darex Container Products Div of W.R. Grace & Co. / initiated 2003-02-11 / Terminated

Darex Container Products Div of W.R. Grace & Co. began a recall of 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... on . The reason FDA records is "Contaminated with epoxy chips". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0731-03
Status
Terminated
Initiated
Posted
Terminated
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
Product code
CBL Absorbent, Carbon-Dioxide
Reason for recall
Contaminated with epoxy chips.
FDA 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 in commerce
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.
Product codes and lots
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.