Events

Recall of Device Recall Biogel Skinsense N Surgical Gloves

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SSL Americas Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25119
  • Event Risk Class
    Class 2
  • Event Number
    Z-0346-03
  • Event Initiated Date
    2002-11-25
  • Event Date Posted
    2002-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25232
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgeon'S Gloves - Product Code KGO
  • 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.

Device

Device Recall Biogel Skinsense N Surgical Gloves
  • Model / Serial
    Lot numbers 01H0161 through 01H2668
  • Product Classification
    General Hospital and Personal Use Devices
  • 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
    SSL Americas Inc.

Manufacturer

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