BEUDAMED
    FDA Recall Terminated

    Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc. Lot Number 01H0161 through 01H2668, sizes: 7-7 , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.

    Recall: Z-0346-03 · Initiated November 25, 2002

    Recall

    Recall Number
    Z-0346-03
    Event Number
    25119
    Firm
    SSL Americas Inc.
    FEI Number
    3002970705
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2002
    Posted
    December 18, 2002
    Terminated
    July 21, 2003
    Address
    3585 Engineering Dr., Norcross, GA, 30092

    Description

    Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc. Lot Number 01H0161 through 01H2668, sizes: 7-7 , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.

    Reason

    Sulfur particles on the surface of gloves.

    Action

    On 11/25/2002 the Company representatives contacted the headquarter offices of the firm's in the U.S. by telephone and in writing by UPS delivery. On 11/26/2002 the Company sent the distributors' branches letters via UPS delivery. Approximately 1500 hospitals (customers of the Company's distributors) were notified by letter via UPS delivery. Customers were instructed to cease distribution of the suspected lot number gloves, contact their customers, and return any remaining gloves via UPS to the recalling firm. A response letter is attached to the recall letter. The Company intends to contact by telephone all of its direct accounts who do not respond to the Recall Letter.

    Distribution

    Various Hospitals, Direct accounts,and Company sales representatives in: AL, AZ,, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI. Foreign Accounts in: Canada, Venezuela and British Colombia. SSL Canada, Concord, Canada; Corporacion Alivari, Caracas, Venezuela; and Wilhelmina Martin, Port Moody, British Colombia. No government accounts involved.

    Quantity

    173,310 pairs