Events

Recall of Merit Medical Surgical Convenience Kits

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
    38950
  • Event Risk Class
    Class 2
  • Event Number
    Z-1262-2007
  • Event Initiated Date
    2007-08-15
  • Event Date Posted
    2007-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54603
  • 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
    Surgical Convenience Kits - Product Code LRO
  • Reason
    Expiration dating; some convenience kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.
  • Action
    An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their consignees.

Device

Merit Medical Surgical Convenience Kits
  • Model / Serial
    Merit Lot Numbers: A339685, A342805, A343855, A344934, A348869, A350784, A350904, A353811, A355556, A357384, A357617, A358608, A360773, A361301, A364800,A365752, A366125, A366523, A367651, A371190, A372815, A374857, A375138, A375848, A376973, A377976, A381997, A384786, A387975, F390117, F399800, F406192, F434870, F440785, F440789, F440801, F440803, F442051, F449479, F449481, F449482, F449483, F453020, F453170, F455150, F456553, F465539, F465540, F470421, F471056, F471659, F473566, F474320, F476314, F476367, F476543, F476597, F477729, F480127, F480129, F480131, F480140, F482129, F482853, F488460, F488709, F488858, F489432, F491275, F491462, F491656, F491659, F492220, F492223, F494547, F495828, F496118, F496939, F502345, F504184, F505776, F505782, F505785, F505786, F505790, F505794, F505799, F508595, F509197, F511015, F513651, F514433, F514954, F514957, F515853, F517537, F517708, F518306, F520504, F523595, F526626, F528413, F534059, F536871, F537731, F538716, F548977, F548978.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 West Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA