BEUDAMED
    FDA Recall Terminated

    Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The label shows the product is Manufactured by Allied Healthcare Products Inc., St. Louis, MO. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications.

    Recall: Z-2152-2011 · Initiated August 12, 2010

    Recall

    Recall Number
    Z-2152-2011
    Event Number
    57044
    Firm
    Allied Healthcare Products Inc
    FEI Number
    1924066
    Product Code
    CBL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2010
    Posted
    May 6, 2011
    Terminated
    March 28, 2012
    Address
    1720 Sublette Ave, Saint Louis, MO, 63110-1927

    Description

    Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The label shows the product is Manufactured by Allied Healthcare Products Inc., St. Louis, MO. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications.

    Reason

    The granules do not absorb as long as expected in the anesthesia machines

    Action

    Allied Healthcare Product, Inc. issued recall letters dated August 10, 2011, via certified mail beginning 8/12/10 and/or via e-mail with a read receipt. Letters were issued for both distributors and end-use customers (such as medical facilities or pharmacies) explaining the reason for recall. Distributors were requested to conduct a subrecall using the enclosed customer letter for end users. A response form was included for both distributors and end users to complete to indicate the amount of product to be returned. The customer was instructed to contact the recalling firm for return instructions. For questions regarding this recall call 314-268-1661.

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, MS, NC, NE, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Canada and Grenada.

    Quantity

    949 pails, 335/12-canister cases, and 706/12-refill bag cases