Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0730-03

High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet...

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 High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as... on . The reason FDA records is "Contaminated with epoxy chips". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0730-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Darex Container Products Div of W.R. Grace & Co.
Product
High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) 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 5-gallon pails under the W.R. Grace label
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
591 5-gallon pails
Distribution
Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.
Product codes and lots
Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05