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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66777

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 30, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0980-2014
Recall number
Z-0980-2014
Initiated
September 30, 2013
Classification
Class I
Status
Terminated
Quantity
20, 872 trays

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.