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
FDA Recall Z-0850-05 · Posted 2005-05-25
Recalling FirmDarex Container Products Div of W.R. Grace & Co.
Recall StatusTerminated
Product CodeCBL
Date Initiated2005-03-31
Date Terminated2006-07-31
Product Quantity360 PrePaks and 18 5-gallon pails
Reason for Recall
Both lots were found to be out of specification due to an elevated level of small particles (fines).
Firm 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.
Root Cause
Other
Distribution Pattern
California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.