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U.S. Department of Health and Human Services

Class 2 Device Recall SODASORB 48 IND HP

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  Class 2 Device Recall SODASORB 48 IND HP see related information
Date Initiated by Firm February 11, 2003
Date Posted April 17, 2003
Recall Status1 Terminated 3 on January 26, 2004
Recall Number Z-0730-03
Recall Event ID 25673
Product Classification Absorbent, Carbon-Dioxide - Product Code CBL
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
Code Information Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05
Recalling Firm/
Darex Container Products Div of W.R. Grace & Co.
6050 W. 51st Street
Chicago IL 60639
For Additional Information Contact Ms. Stephanie A. Blum
Manufacturer Reason
for Recall
Contaminated with epoxy chips.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.