—#123393

Product

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.

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 12701 N Kingston Ave, Chester, Virginia 23836-2700

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-09-30
Posted by FDA: 2014-02-20
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.