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 absorbent is depleted; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton The indicator soda lime product is used for absorption of carbon dioxide in anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, sevoflurane, desflurane and isoflurane.

    Recall: Z-0560-2011 · Initiated October 20, 2010

    Recall

    Recall Number
    Z-0560-2011
    Event Number
    57064
    Firm
    Darex Container Products Div of W.R. Grace & Co.
    FEI Number
    3003940942
    Product Code
    CBL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 20, 2010
    Posted
    December 8, 2010
    Terminated
    September 21, 2011
    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 absorbent is depleted; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton The indicator soda lime product is used for absorption of carbon dioxide in anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, sevoflurane, desflurane and isoflurane.

    Reason

    Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers.

    Action

    Darex/W.R. Grace sent a Customer Notification to their sole direct account of the recall and the account provided Darex/W.R. Grace with lists of their customers who received the recalled products. Darex then sent undated recall letters to those accounts on 10/20-22/10. The accounts were informed of the product, the problem, and the action that should be taken. The accounts were warned not to use Pre-Pak units with missing or illegible expiration dates and/or batch numbers and were requested to examine their inventories of Pre-Pak units, placing all units that had missing or illegible expiration dates and/or batch numbers on hold for destruction and replacement. The accounts were instructed to call W.R. Grace at 1-800-492-7632 to arrange for replacement. The accounts were also requested to complete and return the reply postcard, indicating how much product was destroyed.

    Distribution

    Nationwide Distribution

    Quantity

    95,542 cartons