Device Recall Biogel Skinsense N Surgical Gloves

  • Model / Serial
    Lot numbers 01H0161 through 01H2668
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    SSL Americas Inc., 3585 Engineering Dr., Norcross GA 30092
  • Source
    USFDA