Events

Recall of EasyTouch (ET) Insulin Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MHC Medical Products LLC.

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
    79950
  • Event Risk Class
    Class 2
  • Event Number
    Z-1779-2018
  • Event Initiated Date
    2018-04-06
  • 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=164017
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    The retail shelf cartons may be labeled with an incorrect lot number.
  • Action
    Notification letters distributed on 4/6/18 and 4/11/18 included the following instructions: Please identify your total inventory for this device. The lot number for this device is a five-character, numeric representation (45014). This number can be located on the reverse side of the poly bag (immediate package) near the UDI /QR code. On the retail shelf carton, the lot number (45014) can be located on the rear panel near the UDI/QR code. Finally, the lot number (45014) can be located on the side panels of the case carton near the Item# and expiration date. Please take the following actions immediately: " Cease distribution of this lot number of devices; " Segregate the above described devices; " Complete the attached Consignee Reply Form and return it, even if you have no inventory on hand, to us using the enclosed self-addressed, stamped envelope, and " Return all unused devices from this lot in your inventory, if any, using via UPS Ground, UPS #A68W74 to the following address: MHC Medical Products, LLC c/o RXTPL 4200 Binion Way, Suite 200 Mason OH 45036 If you are a wholesaler (distributor), MHC is requesting that you notify any accounts or additional locations that may have received these recalled devices in lot 45014. If you prefer that MHC notify your customers, please provide MHC with a list of your companys customers that received or have been shipped the recalled lot 45014, including the customers name, shipping address, and contact phone number and/or e-mail address that you have on record. If you are a retail pharmacy, MHC is requesting you to notify your customers that received these recalled devices in lot 45014. Please instruct all customers to return the devices either to your pharmacy or instruct them to call the MHC customer service line (877-358-4342) and MHC will provide additional recall instructions directly to the customer. If you are a customer for whom MHC drop-ships devices to your end customer, please be aware that w

Device

EasyTouch (ET) Insulin Syringe
  • Model / Serial
    Lot 45014
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.
  • Product Description
    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) || Product Usage: || INTENDED FOR INJECTION OF U100 INSULIN ONLY
  • Manufacturer
    MHC Medical Products LLC

Manufacturer

MHC Medical Products LLC
  • Manufacturer Address
    MHC Medical Products LLC, 11930 Kemper Springs Dr, Cincinnati OH 45240-1642
  • Manufacturer Parent Company (2017)
    Mhc Medical Products Llc
  • Source
    USFDA