Events

Recall of Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    78464
  • Event Risk Class
    Class 2
  • Event Number
    Z-0162-2018
  • Event Initiated Date
    2017-10-23
  • Event Date Posted
    2017-11-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159624
  • 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
    Possible open seal on top portion of the package. could cause breach of sterility.
  • Action
    Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.

Device

Sensicare Green Polyisoprene Surgical Glove with Aloe Vera, Size 8.5, MSH1285, Lot Number 7018933694
  • Model / Serial
    Model No. MSG1285, Lot No. 701893369485
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
  • Product Description
    Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. || Surgical glove.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA