CLASS I Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
Merit Medical's Custom Procedural Trays or Kits recalled
Merit Medical Systems is recalling Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, distributed nationwide in the US. The recall was initiated on 30 Sep 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0980-2014
- FDA event ID
- 66777
- Recalling firm
- Merit Medical Systems, Chester, VA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Sep 2013
- FDA classified
- 20 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 30 Sep 2013 | Recall initiated by company | |
| 20 Feb 2014 | Classified by FDA | +143 days |
| 26 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Is Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection recalled?
Yes. Merit Medical Systems recalled Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection on 30 Sep 2013. The recall is Class I and its status is Terminated. Recall number Z-0980-2014.
Why was it 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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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