Events

Recall of Device Recall Reprocessed Zimmer Tourniquet Cuffs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by STERILMED, 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
    72035
  • Event Risk Class
    Class 2
  • Event Number
    Z-2819-2015
  • Event Initiated Date
    2015-08-24
  • Event Date Posted
    2015-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139625
  • 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
    Tourniquet, pneumatic - Product Code KCY
  • Reason
    Sterilmed, inc. is recalling its reprocessed zimmer tourniquet cuff, part #zim60-7075-106, lot number 1846885 due to mislabeling. the affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
  • Action
    Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078.

Device

Device Recall Reprocessed Zimmer Tourniquet Cuffs
  • Model / Serial
    Lot 1846885
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
  • Product Description
    Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. || Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
  • Manufacturer
    STERILMED, INC.

Manufacturer

STERILMED, INC.
  • Manufacturer Address
    STERILMED, INC., 11400 73rd Ave N, Maple Grove MN 55369-5561
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA