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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2364-2026

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

Publicado el 24 de junio de 2026 · Inicio del retiro: 21 de abril de 2026

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

Qué peligro representa

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
ARROW INTERNATIONAL, LLC
Distribuidor
US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Lote
REF(Material)/UDI-DI/Lot(Batch): ASK-04001-SUH-S/10801902210217, 10801902193275/33F25C0766, 33F25E0112, 33F25G0101, 33F25H0058, 33F25H0725, 33F25J0862, 33F25M0836, 33F25F0160; ASK-04001-VM1/10801902210217, 10801902202106, 10801902193275/33F24L0599, 33F26A0962, 33F24G0280; AB-19604-KS/10801902210217, 10801902209471/33F24L0608, 33F25G0474, 33F25J0814, 33F25M0887, 33F24D0064; AB-19608-KS/10801902210217, 10801902209471/33F24E0312, 33F24F0295, 33F24G0316, 33F24K0082, 33F24L0714, 33F25E0027, 33F25E0904, 33F25H0003, 33F25J0815, 33F25L0337, 33F26B0498, 33F24E0314; AB-20608-KS/)10801902210217/33F25H0004, 33F25J0816, 33F24D0437; AB-05060-PK/10801902209433, 10801902210217/33F24D0002, 33F24E0029, 33F24G0315, 33F24J0484, 33F24K0081, 33F25A0451, 33F25C0747, 33F25E0026, 33F25J0646, 33F24E0028; ASK-19609-VCU/10801902210217, 10801902206876, 10801902214291/33F24E0536, 33F24J0630, 33F24L0605, 33F25C0179, 33F25E0220, 33F25H0140, 33F26B1003, 33F24D0628; ASK-19600-CC2/10801902210057, 10801902210217, 10801902210064/33F24D0393, 33F24E0533, 33F24G0494, 33F24K0251, 33F24L0665, 33F25C0177, 33F25E0217, 33F25H0138, 33F24C0230; ASK-19608-CC/10801902210217, 10801902210064, 10801902202236/33F24G0309, 33F24K0252, 33F24L0639, 33F25B0691, 33F25C0178, 33F25C0761, 33F25E0218, 33F25E1022, 33F25H0750, 33F25J0918, 33F26B0230, 33F24D0394; ASK-19608-KP/10801902210217/33F24G0495, 33F24G0086; ASK-19608-SHC/10801902210217, 40801902202220, 10801902202243/33F24G0496, 33F24J0629, 33F24K0253, 33F24L0573, 33F25A0571, 33F25C0733, 33F25E0219, 33F25G0757, 33F25H0139, 33F25J0919, 33F25K0400, 33F25L0480, 33F26B0606, 33F24C0231; FB-19608-K/10801902210217, 10801902210125/33F24G0533, 33F24J0650, 33F24K0279, 33F24L0568, 33F25C0186, 33F25C0748, 33F25E0257, 33F25G0147, 33F25H0164, 33F25J0623, 33F25L0340, 33F25M0847, 33F24C0258; FB-19608-KU/10801902210217, 10801902210132/33F24E0026, 33F24E0574, 33F24G0312, 33F24J0328, 33F24L0557, 33F24M0268, 33F25C0187, 33F25C0940, 33F25E0258, 33F25H0165, 33F25J0624, 33F25L0344, 33F25M0851, 33F23G0580; FB-19609-K/10801902210132, 10801902210217, 10801902210132, 10801902210149/33F24C0259, 33F24D0407, 33F24E0575, 33F24G0534, 33F24K0281, 33F24L0805, 33F25C0721, 33F25E1042, 33F25J0625, 33F25L0351, 33F25M0856, 33F26B0504, 33F24B0386; FB-19609-KU/10801902210149, 10801902210217, 10801902210149, 10801902193275/33F24C0260, 33F24E0576, 33F24E0577, 33F24G0535, 33F24L0763, 33F25A0592, 33F25E0259, 33F25E1043, 33F25H0758, 33F25K0402, 33F25L0471, 33F26B0594, 33F26C0480, 33S24L0763, 33F24L0738; ASK-19608-US1/10801902210217/33F24E0535, 33F24K0254, 33F24L0770, 33F24E0014; ASK-05001-SLR1/10801902210217, 10801902209617/33F24J0596, 33F24L0560, 33F25A0546, 33F25C0939, 33F25E0177, 33F25E0998, 33F25J0530, 33F24C0194; MH-05001/10801902210217/33F24G0540, 33F24J0331, 33F24J0654, 33F25E0261, 33F25H0168, 33F25J0937, 33F25L0478, 33F24K0286; WJ-05401/10801902210385, 10801902210217, 10801902210385/33F24B0166, 33F24C0054, 33F24J0672, 33F24K0307, 33F24L0548, 33F25A0609, 33F25A0625, 33F25C0723, 33F25E0285, 33F25E1062, 33F25G0156, 33F25H0187, 33F25J0640, 33F25J0952, 33F25L0414, 33F26B0559, 33F26C0858; ASK-05501-USC1/10801902210217, 10801902214857, 10801902209853/33F24E0506, 33F24E0507, 33F24G0478, 33F24L0561, 33F25A0561, 33F25C0167, 33F25C0769, 33F25E0200, 33F25G0132, 33F25H0745, 33F25J0908, 33F25L0412, 33F26B0557, 33F24C0211; LG-03000/10801902210217/33F24L0668, 33F24E0581; MTO-03000-VM/10801902210217, 10801902202076, 10801902119916/33F24E0586, 33F24G0547, 33F24J0658, 33F24K0291, 33F24L0632, 33F25A0596, 33F25C0869, 33F25E0265, 33F25H0173, 33F25J0939, 33F25L0380, 33F26C0306, 33F24A1057; SM-03001/10801902210217, 10801902202496, 10801902210354/33F24E0779, 33F24J0243, 33F24J0434, 33F24M0012, 33F25A0099, 33F25B0035, 33F25B0128, 33F25C0410, 33F25C0521, 33F25F0421, 33F25G0531, 33F25J0053, 33F25L0171, 33F26B0643, 33F24C0276; FB-19611-K/10801902210156/33F24F0014
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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