Events

Recall of Fluid Administration Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, 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
    75011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0649-2017
  • Event Initiated Date
    2016-08-12
  • Event Date Posted
    2016-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149111
  • 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
    Merit medical systems, inc. announces a voluntary field action for fluid administration sets due to a molding defect in the drip chamber.
  • Action
    Consignees were notified via an Urgent Product Recall Notice on 8/12/16 to: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Complete the Customer Response Form and return it to Merit Medical Systems with any affected products. If you have no affected products, please complete the Customer Response Form. 4. E-mail the completed Customer Response Form to Customer Service at RESPONSE@merit.com, or fax to (801) 316-4880. 5. If you have any questions concerning this communication or for assistance arranging product return, please dont hesitate to contact your Merit Sales Representative or Vicki Biehn at vbiehn@merit.com or at (801) 208-4260.

Device

Fluid Administration Sets
  • Model / Serial
    Part Number: 701610001, K08-02053A, K08-02111A, K-08-2192A, K08-02385, K08-02385P, K08-02649, K08-02690, K08-02930a, K08-03044, K08T-02829, K09-00807AD, K09-01467AC, K09-01467AD, K09-01732N, K09-02334N, K09-02608A, K09-03491HP, K09-03586AC, K09-03743L, K09-04300Q, K09-04775HP, K09-04916JP, K09-05525A, K09-05648GP, K09-05993F, K09-07692D, K09-08374C, K09-08485F, K09-08556G, K09-08592N, K09-08603B, K09-08720G, K09-08720H, K09-08743L, K09-08743M, K09-08790C, K09-08813J, K09-09067C, K09-09144B, K09-09221CP, K09-09280A, K09-09326, K09-09418CP, K09-09439, K09-09474H, K09-09527D, K09-09657AP, K09-09672AP, K09-09677A, K09-09683l, K09-09683LP, K09-09859FP, K09-09966AP, K09-09966BP, K09-09983A, K09-10008C, K09-10009D, K09-10312, K09-10457C, K09-10590, K09-10593A, K09-10745BP, K09-10784A, K09-10800CP, K09-10870C, K09-10915F, K09-10947J, K09-10947LP, K09-10992CP, K09-11004F, K09-11004FP, K09-11132CP, K09-11132DP, K09-11137A, K09-11165B, K09-11259B, K09-11270A, K09-11303, K09-11303A, K09-11306, K09-11309D, K09-11336B, K09-11389, K09-11433F, K09-11452AP, K09-11530P, K09-11549D, K09-11655A, K09-11704, K09-11796C, K09-11796CP, K09-11867AP, K09-11901B, K09-11912, K09-11923C, K09-11940AP, K09-11971B, K09-12000, K09-12000A, K09-12006, K09-12065CP, K09-12065D, K09-12065DP, K09-12123A, K09-12138, K09-12138A, K09-12138B, K09-12216, K09-12276, K09-12304, K09-12305, K09-12356, K09-12376, K09-12393, K09-12408, K09-12408A, K09-12421, K09-12431, K09-12529, K09-12530, K09-12530P, K09-12562P, K09-12610, K09-12610P, K09-12647, K09-12689, K09-12698, K09T-03491C, K09T-09672G, K09T-10728C, K09T-11022C, K09T-11410C, K09T-11796C, K09T-11796D, K09T-11940A, K09T-12624, K10-05097A, K11-01028, K11-01376, K12T-06138A, K12T-07389A, and K12T-08215.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Custom Fluid Management Set, Sterile, EO, Rx Only || Used to transfer contrast media and saline from a container to a patients || vascular system.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA