Events

Recall of Device Recall Zyno Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zyno Medical 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
    74892
  • Event Risk Class
    Class 2
  • Event Number
    Z-2894-2016
  • Event Initiated Date
    2016-07-29
  • Event Date Posted
    2016-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148697
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Administration set potential filter leaking.
  • Action
    Zyno issued Recall letter dated July 26th, 2016 to affected customers. Customers who received affected products were contacted between 7/29/2016 and 8/1/2016. Customers were asked to return unused product for replacement. For questions contact Customer Service Representative, at 508-907-7796, or laryloring@zynomed.com. Expanded Recall: Two recall letters issued on 11/3/2016 to address the newly identified lots. One letter for customers who received the initial recall letter and the other letter for newly affected customers who did not receive the initial recall letter.

Device

Device Recall Zyno Medical
  • Model / Serial
    Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Zyno Medical Administration Set, Sterile. Rx || For Use with Zyno Medical Infusion Pumps or Gravity Feed || Product Code: A2-80072-F || Product Usage: || Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
  • Manufacturer
    Zyno Medical LLC

Manufacturer

Zyno Medical LLC
  • Manufacturer Address
    Zyno Medical LLC, 10 Tech Cir, Natick MA 01760-1029
  • Manufacturer Parent Company (2017)
    Zyno Medical Llc
  • Source
    USFDA