BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0850-05 · Initiated March 31, 2005

    Recall

    Recall Number
    Z-0850-05
    Event Number
    31687
    Firm
    Darex Container Products Div of W.R. Grace & Co.
    FEI Number
    3003940942
    Product Code
    CBL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 31, 2005
    Posted
    May 25, 2005
    Terminated
    July 31, 2006
    Address
    6050 W 51st St, Chicago, IL, 60638-1405

    Description

    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

    Reason

    Both lots were found to be out of specification due to an elevated level of small particles (fines).

    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.

    Distribution

    California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia

    Quantity

    360 PrePaks and 18 5-gallon pails