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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 March 31, 2005
Date Posted May 25, 2005
Recall Status1 Terminated 3 on July 31, 2006
Recall Number Z-0850-05
Recall Event ID 31687
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 & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails
Code Information pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006
Recalling Firm/
Manufacturer		 Darex Container Products Div of W.R. Grace & Co.
6050 W 51st St
Chicago IL 60638-1405
For Additional Information Contact Ms. Stephanie A. Blum
617-498-4357
Manufacturer Reason
for Recall		 Both lots were found to be out of specification due to an elevated level of small particles (fines).
FDA Determined
Cause 2		 Other
Action Recall letters dated 3/30/05 were sent to the accounts via DHL on 3/31/05, informing them that the two lots did not undergo final QC testing prior to shipment and do not meet finished product specifications. The accounts were requested to check their inventory for the affected lots, discontinue use and place it on hold pending return to W.R. Grace for replacement. Any questions were directed to the Sodasorb Recall Coordinator at 1-877-327-3987.
Quantity in Commerce 360 PrePaks and 18 5-gallon pails
Distribution California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
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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