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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0980-2014

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.

Publicado el 26 de febrero de 2014 · Inicio del retiro: 30 de septiembre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Merit Medical Systems, Inc.
Distribuidor
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.
Lote
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-5
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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