GraveFDAEn curso
Puede causar una enfermedad grave o la muerte. No lo coma.
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L
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): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25J0198, 33F26B0228, 33F26B0831, 33F26C0534; CDC-34041-VPS/10801902193275/33F24L0236; CDC-35052-VPS/10801902193275/33F25E0425; ASK-04001-BWK2/10801902193275/33F25A0226, 33F25D0389, 33F25E0519, 33F25F0076, 33F25F0139, 33F25H0660, 33F25J0347, 33F26A1341; ASK-04001-DU11/10801902193275/33F25C0425, 33F25D0328, 33F25F0140, 33F25H0506; ASK-42703-PVD/10801902156966, 10801902193275/33F24F0977, 33F24L1004, 33F25C0302, 33F25K0144, 33F26B0157; ASK-12703-LMDTG1/10801902193275, 10801902205688/33F25D0262, 33F25G0280, 33F26B0212; ASK-15703-ECMC4/10801902159950, 10801902193275/33F24E0649, 33F24F1039, 33F25B0439; ASK-15703-PNM/10801902193275/33F25E0312; ASK-22123-UAB/10801902144956, 10801902193275/33F24F0854, 33F24L0318, 33F25C0281, 33F25D0267, 33F25D0593, 33F25J0380; CDC-24402-X1A/10801902193275, 10801902168099/33F24L1111, 33F25C0206, 33F25E0747, 33F25G0341, 33F25H0554, 33F25J0324, 33F26A1561, 33F26B0165, 33F26B0803; CDC-25123-X1A/10801902193275, 10801902168105/33F25B0675, 33F25D0501, 33F25E0887, 33F25G0379, 33F26A1562, 33F26B0892; ASK-42703-CPR/10801902193275, 10801902135220/33F25C0744, 33F25E0234, 33F25J0559, 33F25J0797, 33F25K0401, 33F26B0244; ASK-42802-DMC2/10801902193275/33F25E0005; ASK-45802-PCMH1/10801902193275/33F25D0034; ASK-42703-MM1/10801902193275, 10801902221916/33F25E0509, 33F25E0559, 33F25M0205, 33F25M0449, 33F26A1659, 33F26B0196; ASK-42703-PHUMC1/10801902193275/33F25E0009, 33F25G0174, 33F25G0682, 33F25L0138, 33F26A0234; ASK-42703-PMSG1/10801902193275/33F25F0363; ASK-42703-POSU3/10801902193275, 10801902222579/33F25D0758, 33F25E0563, 33F25L0109, 33F26A1436, 33F26B0782; ASK-42703-PSAU1/10801902193275, 10801902159486/33F25A0258, 33F25C0300, 33F25D0543, 33F25J0108, 33F25J0273, 33F25M0093, 33F26B0758; ASK-42703-RHR1/10801902193275, 10801902163643/33F25E0311, 33F25G0262, 33F25H0425, 33F25L0060, 33F26A0238, 33F26C0483; ASK-42802-DU1/10801902161007, 10801902193275/33F24C0924, 33F24F0870, 33F24L0870, 33F25D0356, 33F25E0566, 33F25F0191, 33F25J0285, 33F26B0423; ASK-42802-PHF4/10801902200485, 10801902193275/33F24F0759, 33F25B0357, 33F25B0478, 33F25E0568, 33F25F0079, 33F25G0176, 33F25J0392, 33F25M0059, 33F26A1528, 33F26B0190, 33F26B0793; ASK-42802-PHHN1/10801902193275/33F25E0004, 33F25G0265, 33F25K0045, 33F25M0065; ASK-42802-POSU3/10801902193275, 10801902222586/33F25D0759, 33F25E0569, 33F25F0193, 33F25G0186, 33F25J0393, 33F26A1548, 33F26B0859; ASK-42802-PUCD1/10801902193275/33F25E0313, 33F25E1206; ASK-42802-PWHC1/10801902193275, 10801902134858/33F25B0498, 33F25E0680, 33F25F0195, 33F25J0160, 33F26B0418, 33F26C0164; ASK-42802-UHC/10801902193275, 10801902159745/33F25C0306, 33F25E0605, 33F25J0289, 33F26B0200; ASK-42854-MCY1/10801902193275, 10801902220995/33F24H0126, 33F24J0099, 33F25B0479, 33F25E0570, 33F25F0196, 33F25J0396, 33F26B0779; ASK-45703-BCH/10801902193275, 10801902222784/33F25F0004, 33F25F0117, 33F25G0184, 33F25G0185, 33F25H0508, 33F26A1381, 33F26B0876; ASK-45703-EMC/10801902160468, 10801902193275/33F24D0579, 33F24L0911, 33F25D0411, 33F25G0406, 33F25M0181, 33F26C0225; ASK-45703-MHMC1/10801902193275, 10801902213850/33F25B0580, 33F25D0366, 33F25E0574, 33F25G0224, 33F25H0463, 33F25J0231, 33F26B0129; ASK-45703-NWM/10801902193275/33F25F0006, 33F25F0105, 33F25M0009, 33F26A1463; ASK-45703-PCOR/10801902193275/33F24L0088, 33F25C0736, 33F25H0755; ASK-45703-PIMH/10801902193275/33F25B0588; ASK-45703-PK/10801902193275/33F25A0271, 33F25E0623; ASK-45703-PLGH2/10801902144536, 10801902193275/33F24D0901, 33F24F0995, 33F24L0213, 33F24L0964, 33F25C0315; ASK-45703-PMM4/10801902193275/33F25A0272; ASK-45703-PMM5/10801902193275, 10801902221947/33F25E0505, 33F25E0624, 33F25G0192, 33F25L0105, 33F25L0269, 33F26A1368, 33F26B0207, 33F26C0153; ASK-45703-POSU3/10801902193275, 10801902222593/33F25D0760, 33F25E0576, 33F25E0686, 33F25M0097, 33F26A1346, 33F26B0148, ASK-45703-PPHP1/10801902193275/33F24K0067, 33F25C0584, 33F25G0555, 33F26A0240; ASK-45703-PSAM/10801902116373, 10801902193275/33F24E0560, 33F24G0518, 33F24J0638, 33F25C0818, 33F25G0144, 33F25J0931, 33F26B0509; ASK-45703-PUCD1/10801902193275, 10801902221640/33F25D0237, 33F25D0607, 33F25H0653, 33F25K0159, 33F25M0228, 33F26A1499, 33F26B0374; ASK-45703-PUNCC2/10801902164268, 10801902193275/33F24D0696, 33F24F0690, 33F24K0439, 33F25B0598,33F25D0373, 33F25E0690, 33F25F0147, 33F25H0204, 33F25H0631, 33F25J0233, 33F26B0415; ASK-45854-PAMC1/10801902193275/33F25C0363, 33F25H0519, 33F25K0162, 33F26A0524; ASK-45854-PLGH1/10801902193275/33F24L0191, 33F25B0361, 33F25E0309, 33F25H0775, 33F26A0247; CDC-45802-XPN1A/10801902193275/33F25A0290, 33F25B0632, 33F25E0757, 33F25J0255, 33F26A1565; CDC-42703-XPN1A/10801902193275, 10801902162066/33F25F0069, 33F25F0332, 33F25H0879, 33F25H0881, 33F25J0224, 33F25J0693, 33F25J0697, 33F25J0717, 33F25J0721, 33F25L0014, 33F25L0250, 33F25M0019, 33F25M0028,33F26A0312, 33F26A0338, 33F26B0624, 33F26C0066, 33F26C0074, 33F26C0087, 33F26C0101, 36F25A0010, 36F25B0035, 36F25B0038, 36F25B0069, 36F25E0017, 36F25G0013, 36F25H0001, 36F25H0002, 36F25H0026, 36F25J0003; CDC-45703-PB1A/10801902117202, 10801902193275/33F24C1072, 33F24E0626, 33F24F0945, 33F25E0754, 33F25G0581, 33F25H0435, 33F25J0118, 33F25J0328; CDC-45854-P1A/30801902117275/33F24D0700, 33F24F0086, 33F24F0794, 33F25C0210, 33F25D0571, 33F25E0705, 33F25G0276, 33F25H0444, 33F25J0121, 33F25J0184, 33F25K0191, 33F26A1558, 33F26B0886;
- 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