Events

Recall of Merit Medical's Custom Procedural Trays

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
    66777
  • Event Risk Class
    Class 1
  • Event Number
    Z-0980-2014
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123393
  • 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
    Saline, vascular access flush - Product Code NGT
  • Reason
    Custom procedural trays/kits contain 1% lidocaine hcl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. the particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax.
  • Action
    Merit Medical sent via FedEx an "URGENT PRODUCT RECALL NOTICE" dated September 30, 2013 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were given two options: 1) Based upon immediate patient need, they can keep the affected trays and discard the Lidocaine at the point of use (a) Merit will provide the customer with warning labels, along with replacement Lidocaine for each affected tray based on their current inventory or (b) The label will instruct the user to dispose of the Lidocaine at the point of use and replace it with the new lot. 2) They may return all affected trays remaining in inventory to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form and immediately fax a copy of the completed Customer Response Form to Joyce Braxton at 1-801-316-4852 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. If you choose to return the trays, please return the trays as instructed on the Customer Response Form. If customers choose to keep the trays, Merit can send them labels and Lidocaine upon receipt of the Customer Response Form. If you have any questions, please call 1-804-416-1048 and/or 1-801-316-4822. For questions regarding this recall call 804-416-1030.

Device

Merit Medical's Custom Procedural Trays
  • Model / Serial
    Tray/Kit SPPT-5F-10/D, Lot # T491273 , Exp. 31-Dec-2014, SPPT-5F-10/D, Lot # T512967, Exp.31-Dec-2014, K12T-04453, Lot # T472220, Exp. 31-Dec-2014, K12T-04454, Lot # T487452, Exp. 31-Dec-2014, K12T-04455B, Lot # T479169, Exp. 31-Dec-2014, K12T-04455B, Lot # T502497, Exp. 31-Jul-2014, K12T04455B, Lot #T479169, Exp. 31-Dec-2014, K12T-03650C, Lot #T483624, Exp. 31-Oct-2014, K12T-04082B, Lot #T479165, Exp. 31-Oct-2014, K12T-06488, Lot #T475046, Exp. 30-Nov-2014, SPPT-5F-10/D, Lot #T51296, Exp. 31-Dec-2014, SPPT-5F-10/D, Lot #T491273, Exp. 31-Dec-2014, TAPS-5F-10LT, Lot #T486378, 31-Dec-2014, TAPS-5F-10T, Lot#T486379, 31-Dec-2014, SPPT-5F-10L/B, Lot #T486376, 31-Dec-2014, K12T-06292, Lot #T502623, 31-Dec-2014, SPPT-5F-7L/B, Lot #T486377, 31-Dec-2014, SPPT-5F-7L/B, Lot #489467, 31-Dec-2014, K12T-03502A, Lot #T506171, 31-Dec-2014, K12T-04021D, Lot #T450842, 31-Dec-2014, K12T-04021D, Lot #T521882, 31-Dec-2014, K12T-04174A, Lot #T489860, 31-Dec-2014, K12T-04174A, Lot# T496696, 31-Dec-2014, SPPT-5F-10/D, Lot #T491273, 31-Dec-2014, PPT-5F-10/D, Lot #T485986, 31-Dec-2014, TAPS-5F-10LT, Lot #T466554, 31-Dec-2014, TAPS-5F-10LT, Lot #T486378, 31-Dec-2014, TAPS-5F-10LT, Lot #T489468, 31-Dec-2014, K12T-03347, Lot #T478804, 31-Dec-2014, K12T-03425C, Lot #489341, 31-Dec-2014, K12T-05704, Lot #T492544, 31-Dec-2014, SPPT-5F-7/D, Lot #T489466, 31-Dec-2014, K12T-06493A, Lot #T48492, 30-Apr-2014, K09T-11022C. Lot #T483912, 31-Dec-2014, K12T-04001, Lot #T463981, 31-Dec-2014, K12T-05568A, Lot #481071, 30-Nov-2014, SPPT-5F-10S, Lot #T468623, 31-Oct-2014, K10T-04655A, Lot #T484345, 31-Dec-2014, SPPT-100/D, Lot #T478020, 31-Dec-2014, TAPS-5F-10T, Lot #T489469, 31-Dec-2014, K12T-05115A, Lot #T479730, 31-Dec-2014, K12T-03903A, Lot #T468576, 31-Dec-2014, K09T-10692B, Lot #T483949, 31-Dec-2014, K12T-02098, Lot #T483019, 31-Dec-2014, K12T-05386, Lot #T520848, 31-Dec-2014, K10T-04192G, Lot #T472284, 31-Dec-2014, SPPT-5F-7S, Lot #T485990, 31-Oct-2014, K12T-05329D, Lot #T499996, 31-Dec-2014, K10T-04359C, Lot #T491197, 31-Dec-2014, K12T-05060A, Lot #T489355, 31-Dec-2014, K12T-02018, Lot #T491199, 31-Dec-2014, SPPT-5F-10L/B, Lot #T479774, 31-Dec-2014, K12T-04435B, Lot #T495759, 31-Dec-2014, SPPT-5F-10S, Lot #T485989, 31-Oct-2014, K12T-06101B, Lot #T481074, 31-Dec-2014, TAPS-5F-7T, Lot #T485991, 30-Nov-2014, K12T-06287A, Lot #T462949, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, SPPT-5F-7, Lot #T510218, 31-Dec-2014, K12T-03901, Lot #T463979, 31-Dec-2014, K12T-03902A, Lot #T512294, 31-Dec-2014, K12T-04980, Lot #T470847, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, K12T-04456B, Lot # 71869, 31-Dec-2014, K12T-03561, Lot #T467852, 31-Dec-2014, SPPT-5F-10L/B, Lot #T489465, 31-Dec-2014, TAPS-5F-10T, Lot #T481081, 30-Nov-2014, K12T-02007F, Lot #T486261, 31-Dec-2014, K12T-02363B, Lot #484028, 31-Dec-2014, K12T-02363B, Lot #T512726, 31-Dec-2014, SPPT-5F-10/D, Lot #T485986, 31-Dec-2014, K12T-04304, Lot #T489552, 31-Dec-2014,  SPPT-5F-10L/B, Lot #T479774, 31-Dec-2014, K10T-05012A, Lot #T484002, 31-Dec-2014, K10T-04888, Lot #T486289, 31-Dec-2014, K12T-05174, Lot #T492047, 31-Dec-2014, K10T-04675F, Lot #T487475, 31-Dec-2014, K10T-04675G, Lot #T518264, 31-Dec-2014, K12T-04435B, Lot #T495759, 31-Dec-2014, K12T-06083, Lot #T483641, 31-Dec-2014, K12T-05166A, Lot #T487355, 31-Dec-2014, K12T-04677, Lot #T466757, 31-Dec-2014, K12T-04677A, Lot #T510170, 31-Dec-2014, SPPT-5F-10S, Lot #T485989, 31-Oct-2014, K12T-04160B, Lot #T483084, 31-Dec-2014, K12T-05998, Lot #T472000, 31-Jan-2014, K12T-05273A, Lot #T476294, 31-Dec-2014, K12T-04627F, Lot #T487035, 31-Dec-2014, TAPS-5F-10LT, Lot #T489468, 31-Dec-2014, K12T-04127A, Lot #T464325, 31-Dec-2014, K12T-04640, Lot #T487454, 31-Dec-2014, K12T-04848B, Lot #T511337, 31-Dec-2014, K12T-05394A, Lot #T478001, 31-Dec-2014, K12T-01938C, Lot #T478794, 31-Dec-2014, K12T-02657C, Lot #T485373, 31-Jul-2014, SPPT-5F-10S, Lot #T485989, 31-Oct-2014, SPPT-5F-7L/B, Lot #T479775, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, K05T-01920D, Lot # 483910, 30-Nov-2014, K12T-01938C, Lot #T478794, 31-Dec-2014, K12T-05377, Lot #T481002, 31-Dec-2014, K12T-04145B, Lot #T488076, 31-Dec-2014, TAPS-5F-10LT, Lot #T489468, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, K12T-05071A, Lot #T519206, 31-Dec-2014, K12T-04208B, Lot #T483724, 31-Dec-2014, K12T-06282, Lot #T479334, 31-Dec-2014, K12T-06820, Lot #T486372, 31-Dec-2014, K12T-06821, Lot #T486274, 31-Dec-2014, K12T-05608, Lot #T483747, 31-Dec-2014, SPPT-5F-10S, Lot #T485989, 31-Oct-2014, K12T-02452A, Lot #T471426, 31-Dec-2014, K12T-02452A, Lot #T492773, 31-Dec-2014, K12T-05902A, Lot #T490425, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, SPPT-5F-7L/B, Lot #T510218, 31-Dec-2014, K10T-04110B, Lot #T469318, 31-Dec-2014, SPPT-5F-7L/B, Lot #T479775, 31-Dec-2014, K12T-03565C, Lot #T487516, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, K12T-05486, Lot #T501960, 31-Dec-2014, K10T-04147C, Lot #T489535, 31-Dec-2014, K12T-02962, Lot #T489404, 31-Dec-2014, K12T-06612, Lot #T486097, 31-Dec-2014, K12T-03486, Lot #T490408, 31-Oct-2014, SPPT-5F-10L/B, Lot #T486376, 31-Dec-2014, SPPT-5F-10/D, Lot #T512967, 31-Dec-2014, TAPS-5F-10T, Lot #T481081, 30-Nov-2014, K12T-04028C, Lot #T492811, 31-Dec-2014, K12T-04110B, Lot #T464324, 31-Dec-2014, K12T-04110B, Lot #T492717, 31-Dec-2014, K12T-02098, Lot #T504336, 31-Dec-2014, K12T-04679, Lot #T479171, 31-Dec-2014, K12T-04679, Lot #T490388, 31-Dec-2014, K12T-06390A, Lot #T481077, 31-Dec-2014, K12T-06698, Lot #T476670, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, K12T-05049, Lot #T461915, 31-Dec-2014, K12T-04770, Lot #T479728, 31-Dec-2014, K12T-03726A, Lot #T487389, 31-Dec-2014, TAPS-5F-10LT, Lot #T489468, 31-Dec-2014, K12T-02824A, Lot #T483612, 31-Dec-2014, K12T-02824A, Lot #T489334, 31-Dec-2014, SPPT-5F-7L/B, Lot #T479775, 31-Dec-2014, K12T-03464B, Lot #T477831, 31-Dec-2014, K12T-04685C, Lot #T480991, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, K12-05663A, Lot #T492710, 31-Dec-2014, K12T-05986B, Lot #T478929, 31-Dec-2014, SPPT-5F-10L/B, Lot #T486376, 31-Dec-2014, K12T-05833A, Lot #T487540, 30-Sep-2014, K12T-04961, Lot #T518032, 31-Dec-2014, K12T-02447F, Lot #T486262, 30-Nov-2014, K12T-04659C, Lot #T480990, 31-Dec-2014, K12T-04659C, Lot#T515536, 31-Dec-2014, K12T-04010, Lot#T507536, 31-Dec-2014, K12T-03439B, Lot #T487514, 31-Dec-2014, K12T-03464B, Lot #T477831, 31-Dec-2014, SPPT-5F-7L/B, Lot #T479775, 31-Dec-2014, SPPT-5F-7L/B, Lot #T510218, 31-Dec-2014, K10T-05090, Lot #T519010, 31-Dec-2014, K10T-04338B, Lot #T487474, 31-Dec-2014, K12T-03810D, Lot #T484890, 31-Dec-2014, 12T-06228, Lot #T497035, 31-Dec-2014, K12T-06228A, Lot #T516893, 31-Dec-2014, TAPS-5F-10LT, Lot #T466554, 31-Dec-2014, K12T-03561, Lot #T467852, 31-Dec-2014, K12T-06228, Lot #T497035, 31-Dec-2014, K12T-06228A, Lot #T516893, 31-Dec-2014, K10T-04110B, Lot #T469318, 31-Dec-2014, SPPT-5F-7L/B, Lot #T510218, 31-Dec-2014, K12T-04635A, Lot #T489350, 31-Dec-2014, K12T-04821, Lot #T479729, 31-Dec-2014, K12T-04821, Lot #T508157, 31-Dec-2014, K12T-04581G, Lot #T481065, 31-Dec-2014, K12T-04581J, Lot #T522127, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, K12T-03806F, Lot #T477382, 30-Nov-2014, K12T-04174A, Lot #T496696, 31-Dec-2014, SPPT-5F-7L/B, Lot#T489467, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, K12T-04446A, Lot #T488077, 31-Dec-2014, K12T-06382A, Lot #T472383, 31-Dec-2014, K12T-06382B, Lot #T508372, 31-Dec-2014, K12T-04313A, Lot #T470777, 30-Nov-2014, K12T-04811B, Lot #T473702, 31-Dec-2014, K12T-05367A, Lot #T512415, 31-Dec-2014, K12T-05367A, Lot #T483743, 31-Dec-2014, K12T-06228, Lot #T497035, 31-Dec-2014, K12T-06228A, Lot #T516893, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, SPPT-5F-10/D, Lot #T512967, 31-Dec-2014, K12T-05723A, Lot #T481007, 31-Dec-2014, K12T-05723A, Lot #T519112, 31-Dec-2014, K12T-05723A, Lot #T481007, 31-Dec-2014, SPPT-5F-10L/B, Lot #T489465, 31-Dec-2014, K12T-06432, Lot #483643, 30-Apr-2014, K12T-06433A, Lot #T483762, 30-Apr-2014, SPPT-5F-10L/B, Lot #T486376, 31-Dec-2014, K12T-04821, Lot #T479729, 31-Dec-2014, K12T-04821, Lot #T508157, 31-Dec-2014, K12T-04013C, Lot #T462916, 31-Dec-2014, K12T-03679D, Lot #T466340, 31-Dec-2014, K12T-04922, Lot #T478906, 31-Jul-2014, K12T-06022A, Lot #T488647, 31-Dec-2014, K12T-05202A, Lot #T461918, 31-Dec-2014, K12T-05770, Lot #T468559, 31-Dec-2014, TAPS-5F-10T, Lot #T481081, 30-Nov-2014, TAPS-5F-10T, Lot #T486379, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, SPPT-5F-7L/B, Lot #T479775, 31-Dec-2014, SPPT-5F-7L/B, Lot #T510218, 31-Dec-2014, SPPT-5F-10/D, Lot #T512967, 31-Dec-2014, TAPS-5F-7T, Lot #T491276, 31-Dec-2014, K10T-05068, Lot #T484886, 31-Dec-2014, K10T-05068, Lot #T489807, 31-Dec-2014, SPPT-5F-10L/B, Lot #T510217, 31-Dec-2014, K12T-06814, Lot #T484880, 31-Dec-2014, K12T-06103A, Lot #T483212, 31-Dec-2014, K12T-06103B, Lot #T489457, 31-Dec-2014, K12T-06819, Lot #T48637, 31-Dec-2014, K12T-05808D, Lot #T487463, 31-Dec-2014, K12T-04248D, Lot #T472624, 31-Dec-2014, K12T-04754C, Lot #T484091, 31-Oct-2014, K12T-04905A, Lot #T480996, 31-Dec-2014, K12T-04906A, Lot #T486267, 30-Nov-2014, K12T-03505D, Lot #T482070, 31-Dec-2014, K12T-05687A, Lot #T452489, 31-Dec-2014, K12T-06488, Lot#T475046, 30-Nov-2014, K12T-06293, Lot #T470868, 31-Dec-2014, SPPT-5F-10/D, Lot#T512967, 31-Dec-2014, SPPT-5F-10L/B, Lot#T510217, 31-Dec-2014, K12T-03661A, Lot#T482127, 31-Dec-2014, K12T-04600B, Lot #T479316, 31-Oct-2014, K12T-06701, Lot #475118, 31-Dec-2014, K12T-05028A, Lot#T492723, 31-Dec-2014, K12T-05028A, Lot#T512813, 31-Dec-2014, K12T-05418, Lot#T479323, 31-Dec-2014, K12T-02169B, Lot#T514568, 30-Jun-2014, SPPT-5F-7/D, Lot#T489466, 31-Dec-2014, K12T-02957A, Lot#T487024, 31-Dec-2014, K12T-06412, Lot#T508373, 31-Dec-2014, K12T-06412, Lot#T484904, 31-Dec-2014, K12T-05626, Lot #T479176, 31-Dec-2014, K12T-05807, Lot#T441132,31-Dec-2014, K12T-03975A, Lot #T468577, 31-Dec-2014, K12T-03347, Lot#T478804, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, K12T-04864D, Lot#T477840, 31-Dec-2014, SPPT-5F-7L/B, Lot#T510218, 31-Dec-2014, K12T-04318, Lot#T449731, 31-Dec-2014, K12T-04553A, Lot#T449212, 31-May-2014, SPPT-5F-10L/B, Lot#T489465, 31-Dec-2014, SPPT-5F-10L/B, Lot#T510217, 31-Dec-2014, K12T-05160A, Lot#T495767, 31-Dec-2014, 12T-06462A, Lot#T489802, 31-Dec-2014, K12T-06463, Lot#T482254, 31-Dec-2014, K12T-01852H, Lot#T483814, 31-Dec-2014, K12T-02437A, Lot#T476279, 31-Dec-2014, K12T-04530B, Lot#T500161, 31-Dec-2014, K12T-04530B, Lot#T478216, 31-Dec-2014, K12T-05129B, Lot#T477845, 31-Dec-2014, SPPT-5F-7L/B, Lot#T510218 , 31-Dec-2014, K12T-05404, Lot#T477846, 31-Dec-2014, TAPS-5F-10LT, Lot#T489468, 31-Dec-2014, K12T-04707, Lot#T477980, 31-Dec-2014, K10T-05165A, Lot#T487440, 31-Dec-2014, K12T-06322, Lot#T479735, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, SPPT-5F-7L/B, Lot#T510218, 31-Dec-2014, K12T-04734B, Lot#T478898, 31-Dec-2014, K12T-01751J, Lot#T479859, 31-Dec-2014, K12T-01751J, Lot#T516420, 31-Dec-2014, K12T-01751J, Lot#T479859, 31-Dec-2014, K12T-03675A, Lot#T510051, 31-Dec-2014, K12T-02761F, Lot#T470763, 31-Dec-2014, K12T-05728, Lot#T487358, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, K12T-05586, Lot#T483201, 31-Dec-2014, K12T-02850D, Lot#T441322, 31-Dec-2014, K12T-03228B, Lot#T479162, 31-Dec-2014, K12T-03993A, Lot#T495757, 31-Dec-2014, TAPS-5F-10T, Lot#T481081, 30-Nov-2014, K12T-03993A, Lot#T495757, 31-Dec-2014, TAPS-5F-10T, Lot#T489469, 31-Dec-2014, K12T-04259C, Lot#T476291, 31-Dec-2014, K12T-03048A, Lot#T508582, 31-Dec-2014, K12T-02563B, Lot#T489333, 31-Dec-2014, K12T-02470A, Lot #T483609, 31-Dec-2014, K12T-03063, Lot#T489566, 31-Dec-2014, K12T-01652H, Lot#T464313, 31-Dec-2014, K12T-04848B, Lot#T511337, 31-Dec-2014, SPPT-5F-10/D, Lot#T485986, 31-Dec-2014, SPPT-5F-7L/B, Lot#T510218, 31-Dec-2014, TAPS-5F-7T, Lot # T491276, 31-Dec-2014, K12T-02185G, Lot#T491200, 31-Dec-2014, K12T-03063, Lot#T489566, 31-Dec-2014, K12T-05648, Lot#T518046, 31-Dec-2014, SPPT-5F-7/D, Lot#T489466, 31-Dec-2014, K12T-04013C, Lot#T462916, 31-Dec-2014, K12T-04201A, Lot#T472623, 31-Oct-2014, SPPT-5F-10L/B, Lot#510217, 31-Dec-2014, K12T-04013C, Lot#T462916, 31-Dec-2014, SPPT-5F-7L/B, Lot#T479775, 31-Dec-2014, K10T-01343D, Lot#T487470, 30-Jun-2014, K12T-06221, Lot#T484385, 31-Dec-2014, K12T-04208B, Lot#T483724, 31-Dec-2014
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV.
  • Product Description
    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. || Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA