English
GraveFDAEn curso

Puede causar una enfermedad grave o la muerte. No lo coma.

Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

La agencia publicó este retiro solo en inglés. El nombre del producto y los códigos del paquete se muestran tal como los escribió la agencia, para que coincidan exactamente con su paquete.

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REF(Material)/UDI-DI/Lot(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 10801902193275, 10801902168488/33F24E0342, 33F24F0325, 33F24G0347, 33F24J0512, 33F24K0113, 33F24L0750, 33F25C0109, 33F25C0964, 33F25E0063, 33F25E0926, 33F25J0474, 33F24A0408; AK-12703-CDC/10801902168488, 10801902193275, 10801902168495/33F24A1020, 33F24B0187, 33F24C0104, 33F24D0078, 33F24G0348, 33F24J0513, 33F24K0114, 33F24L0596, 33F25C0110, 33F25C0759, 33F25J0834, 33F25M0948, 33F24A0401; AK-14402/10801902168495, 10801902193275, 10801902168495, 10801902168518/33F24E0177, 33F24E0343, 33F24F0328, 33F24G0349, 33F24J0514, 33F24K0115, 33F25B0369, 33F25C0875, 33F25E0064, 33F25E0928, 33F25H0029, 33F25J0475, 33F26B0564, 33F24A0813; AK-14502/10801902168518, 10801902193275, 30801902122040/33F24E0344, 33F24G0350, 33F24K0116, 33F24L0656, 33F25C0878, 33F25E0065, 33F25G0089, 33F25J0476, 33F26B0568, 33F24A0849; AK-14553/30801902122040, 10801902193275, 10801902122077/33F24B0190, 33F24C0107, 33F24E0345, 33F24E0346, 33F24F0332, 33F24G0351, 33F24K0117, 33F24L0689, 33F25C0112, 33F25C0848, 33F25G0090, 33F25J0835, 33F24B0191; AK-14703-SP/10801902122077, 10801902193275, 10801902197136/33F24E0347, 33F24G0352, 33F24J0516, 33F24K0118, 33F24L0737, 33F25A0476, 33F25C0887, 33F25E0067, 33F25E0929, 33F25J0477, 33F25L0399, 33F25M0905, 33F24D0079; AK-15402/10801902168532, 10801902193275, 10801902168532, 10801902168549/33F24B0194, 33F24E0350, 33F24G0354, 33F24H0034, 33F24J0518, 33F24K0120, 33F24L0751, 33F25A0479, 33F25C0799, 33F25E0069, 33F25E0932, 33F25H0723, 33F25J0836, 33F25L0348, 33F26C0317, 33F24A1268; AK-15553/10801902168549, 10801902193275, 10801902168549, 10801902168563/33F24E0714, 33F24G0226, 33F24G0687, 33F24H0249, 33F24J0353, 33F25B0332, 33F25D0195, 33F25H0796, 33F25J0081, 33F26B0287, 33F24A1269; AK-16402/10801902168563, 10801902193275, 10801902168563, 10801902168570/33F24C0738, 33F24E0715, 33F24H0065, 33F24H0416, 33F24J0212, 33F24J0426, 33F25A0046, 33F25C0087, 33F25C0604, 33F25G0458, 33F25J0082, 33F26A1658, 33F26B0069, 33F26C0446, 33F24A0796; AK-16553/10801902168570, 10801902193275, 30801902122248/33F24E0178, 33F24E0351, 33F24G0355, 33F24J0519, 33F24K0121, 33F24L0790, 33F25C0980, 33F25E0070, 33F25J0478, 33F24C0025; ASK-04301-HH2/10801902193275, 20801902114987/33F25H0640, 33F25K0070, 33F25K0090, 33F24D0733; ASK-12703-MGH3/10801902193275, 10801902115260/33F25D0263, 33F24F0838
Motivo
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.
Distribuido
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.
Empresa
ARROW INTERNATIONAL, LLC
Anunciado
El retiro comenzó
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Local Recall