BEUDAMED
    FDA Recall Terminated

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB80 - size 8; Catalog #SOP69CAFCD and #SOP69CAFCE; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. One pair of size 8 gloves was included as a component of the following Presource Custom Sterile Surgery Packs: Catalog #SOP69CAFCD - Clovis Dr Simonian Arthroscopy Pack; Catalog #SOP69CAFCE - Clovis Dr Simonian Arthroscopy Pack. The affected glove pouch was located outside of the sterile pack. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    Recall: Z-1450-2009 · Initiated April 24, 2009

    Recall

    Recall Number
    Z-1450-2009
    Event Number
    52027
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 24, 2009
    Posted
    June 18, 2009
    Terminated
    May 11, 2010
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB80 - size 8; Catalog #SOP69CAFCD and #SOP69CAFCE; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. One pair of size 8 gloves was included as a component of the following Presource Custom Sterile Surgery Packs: Catalog #SOP69CAFCD - Clovis Dr Simonian Arthroscopy Pack; Catalog #SOP69CAFCE - Clovis Dr Simonian Arthroscopy Pack. The affected glove pouch was located outside of the sterile pack. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.

    Reason

    Increase in the number of customer complaints due to cuff tears.

    Action

    Urgent: Product Recall letters dated 4/24/09 were sent to the direct accounts on 4/24/09 via UPS 2-day mail, to the attention of the Director of Materials Management. The accounts were informed of the increased complaints of cuff tears, and were instructed to stop using them and destroy them. The letter included a list of gloves that could be substituted for the recalled gloves. The accounts were requested to call the appropriate customer service group to arrange for credit for the destroyed product, and to complete and return by fax the enclosed acknowledgement form, indicating the number of gloves destroyed.

    Distribution

    Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.

    Quantity

    29,697 cases total