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U.S. Department of Health and Human Services

Class 2 Device Recall SODASORB 48 IND H MED

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  Class 2 Device Recall SODASORB 48 IND H MED 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-0731-03
Recall Event ID 25673
Product Classification Absorbent, Carbon-Dioxide - Product Code CBL
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
Code Information 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.
Recalling Firm/
Manufacturer		 Darex Container Products Div of W.R. Grace & Co.
6050 W. 51st Street
Chicago IL 60639
For Additional Information Contact Ms. Stephanie A. Blum
617-498-4357
Manufacturer Reason
for Recall		 Contaminated with epoxy chips.
FDA Determined
Cause 2		 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.
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.
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