Device product
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB
Z-2376-2026
Product summary
- Event
- Event 98793
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 308,263
- Official record key
device-enforcement:Z-2376-2026
Official wording
Reason: 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.
Code information: REF(Material)/UDI-DI/Lot(Batch): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325, 33F25B0672, 33F25E0653, 33F25E0877, 33F25M0114, 33F25M0424, 33F26A1508, 33F25A0326; CDC-22123-X1A/10801902193275, 20801902116851, 20801902116851,10801902213591/33F25B0673, 33F25D0446, 33F25D0667, 33F25F0212, 33F25G0413, 33F25J0317, 33F25M0396, 33F26B0442, 33F24D0842; CDC-24301-1A/30801902116902, 10801902193275, 30801902116902, 30801902116919/33F24D0874, 33F24F0076, 33F24F0863, 33F24K0501, 33F24L0979, 33F25B0617, 33F25D0494, 33F25D0668, 33F25E0697, 33F25E0820, 33F25H0571, 33F25J0249, 33F25K0181, 33F25L0084, 33F25L0104, 33F26A1413, 33F26B0784, 33S25E0697, 33F24C0702; AK-22702-P1A/10801902193275, 30801902122378/33F25D0322, 33F25H0424, 33F25J0097, 33F25K0085, 33F24E0364; CDC-22702-XP1A/10801902193275, 30801902116896/33F25D0451, 33F25F0217, 33F25H0573, 33F25J0322, 33F26A1386, 33F26B0706, 33F25K0180; ASK-45703-CPR/10801902193275/33F24J0477, 33F24L1068; ASK-42703-AKP1A/10801902193275, 10801902202519/33F24J0324, 33F25A0577, 33F25C0841, 33F25E0233, 33F25E1027, 33F25G0140, 33F25H0148, 33F25H0754, 33F25J0924, 33F25M0869, 33F24F0754; ASK-42703-KH/10801902193275, 10801902205657/33F24G0269, 33F24L0087, 33F25E0235, 33F25G0141, 33F25L0213, 33F24D0891; ASK-42703-MGH1/10801902193275, 10801902223682, 10801902193275/33F25J0735, 33F26C0344, 33F25E0509; ASK-42703-PCCH2/10801902193275, 10801902141030/33F24L0231, 33F24L0416, 33F24L0945, 33F25B0443, 33F25B0561, 33F25D0352, 33F25E0726, 33F25G0316, 33F25J0155, 33F25M0013, 33F26B0792, 33F26C0228, 33F25D0540; ASK-42703-PFS1/10801902193275/33F25E0598, 33F25B0275; ASK-42703-PNO2/10801902193275/33F26A1661, 33F24L0335; ASK-42703-PSCH1/10801902137330, 10801902193275/33F24F1038, 33F24H0204, 33F25B0566, 33F25H0491, 33F25J0274, 33F25M0092, 33F26B0124, 33F24H0100; ASK-42802-AKP1A/10801902193275, 10801902217155/33F24G0511, 33F24K0264, 33F24L0745, 33F25C0931, 33F25H0150, 33F25J0561, 33F25L0481, 33F25M0971, 33F24F0676; ASK-42802-LMDTG1/10801902193275, 10801902205701/33F26A1254, 33F26B0814, 33F24H0215; ASK-42802-PUCI1/10801902193275/33F24L0195; ASK-42802-PUMH/10801902193275, 10801902164251/33F25H0493, 33F25K0059, 33F25L0141, 33F25M0674, 33F24D0712; ASK-42802-UMM/10801902159653, 10801902193275/33F24F1027, 33F24G0513; ASK-42854-AKP1A/10801902193275, 10801902202540/33F24J0635, 33F24K0265, 33F24L0610, 33F25A0580, 33F25E0239, 33F25H0152, 33F25J0562, 33F24E0632; ASK-42854-MGH/10801902223668, 10801902193275/33F26C0876, 33F25E1198; ASK-45703-AKP1A/10801902193275, 10801902158120/33F24G0515, 33F24J0636, 33F24K0266, 33F24L0577, 33F25A0581, 33F25C0843, 33F25E0241, 33F25G0142, 33F25H0154, 33F25J0564, 33F25L0238, 33F25M0902, 33F24F0106; ASK-45703-MGH/10801902223675/33F26C0875, 33F25B0580; ASK-45703-PCCH2/10801902193275, 10801902141047, 10801902193275/33F24L0356, 33F24L1092, 33F25B0582, 33F25D0550, 33F25E0615, 33F25G0352, 33F25J0163, 33F25K0154, 33F26B0772, 33F24L0088; ASK-45703-PECL1/10801902193275, 10801902130386/33F25E0618, 33F25F0204, 33F25G0289, 33F25J0167, 33F25M0192, 33F26B0191, 33F26B0765, 33F25C0313; ASK-45703-PFS1/10801902193275/33F25E0510, 33F25B0274; ASK-45703-PHM1/10801902193275, 10801902116229/33F25E0620, 33F25G0290, 33F25H0572, 33F25J0405, 33F26B0715, 33F26B0854, 33F25K0313; ASK-45703-PHU/10801902193275/33F25L0135, 33F26A0243, 33F25G0685; ASK-45703-PMSG1/10801902193275, 30801902116315/33F25E1199, 33F25F0357, 33F26A0411, 33F24D0674; ASK-45703-PNCB/30801902116315, 10801902193275/33F24F0818, 33F24L0256, 33F24L1075, 33F25B0592, 33F25D0486, 33F25E0731, 33F25H0433, 33F25M0159, 33F25M0426, 33F26B0760, 33F25B0456; ASK-45703-PPCM/10801902193275, 10801902116335/33F25F0358, 33F25G0688, 33F25K0048, 33F25L0028, 33F26B0903, 33F24K0067; ASK-45703-PRH/10801902193275, 10801902116359, 10801902116373/33F25A0275, 33F25C0318, 33F25E0807, 33F25G0358, 33F25J0301, 33F26A1420, 33F26B0799, 33F24E0560; ASK-45703-PSJ2/10801902193275, 10801902119732/33F25C0319, 33F25E0733, 33F25G0357, 33F25H0641, 33F25J0302, 33F26A1507, 33F26B0878, 33F24L0259; ASK-45703-PSVM/10801902119749, 10801902193275, 10801902119749/33F24F0755, 33F24L0446, 33F25B0459, 33F25C0320, 33F25D0551, 33F25F0120, 33F25G0356, 33F25J0303, 33F26A1523, 33F26B0762, 33F25D0237; ASK-45703-PUHS/10801902193275, 10801902114058/33F24L0942, 33F25B0596, 33F25E0687, 33F25G0303, 33F25H0642, 33F26A1424, 33F24F0717; ASK-45703-PUKL/10801902193275, 10801902114058, 10801902193275/33F24H0185, 33F24K0433, 33F24L0262, 33F25B0597, 33F25D0372, 33F25E0628, 33F25H0566, 33F25J0173, 33F26B0233, 33S25E0628, 33F25B0461; ASK-45703-PUMF1/10801902193275/33F25K0060, 33F25L0134, 33F26A0235, 33F24K0567; ASK-45703-PUR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266, 33F24L0922, 33F25B0601, 33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128,33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-RHR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266,33F24L0922, 33F25B0601,33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128, 33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-WA/10801902193275, 10801902116564, 30801902119774/33F25A0443, 33F25E0011, 33F25K0309, 33F26B0909, 33F24C0746; ASK-45802-AKP1A/10801902193275, 30801902119774/33F24L0023, 33F26A1657, 33F26B0277, 33F25D0034; ASK-45854-AKP1A/10801902193275, 30801902119781/33F24G0671, 33F24L0039, 33F25A0366, 33F25B0094, 33F25D0715, 33F25G0495, 33F25J0033, 33F25K0349, 33F25L0226, 33F26A1654, 33F26B0025, 33F26B0698, 33F24J0130; ASK-45854-MGH/10801902223699, 10801902193275/33F26C0688, 33F25C0363; ASK-45854-PCCH2/10801902193275/33F25J0234, 33F25E1175; ASK-45854-PNM/10801902193275/33F24K0570, 33F25B0431, 33F25E0006, 33F25F0377, 33F25H0780, 33F25L0261; ASK-45854-PPCM/10801902143867/33F24F0736; ASK-45854-PUCH2/10801902193275/33F24M0177; ASK-46702-PWBH1/10801902193275/33F24K0321, 33F24K0269; CDC-42802-P1A/10801902170870, 10801902193275, 10801902170870/33F24F0244, 33F24H0070, 33F24H0426, 33F24J0223, 33F24J0468,33F24L0009,33F24M0079, 33F24M0139, 33F25B0319, 33F25C0533, 33F25E1094, 33F25E1156,33F25F0384, 33F25H0338, 33F25J0766, 33F25J0990, 33F25L0086, 33F25M0016, 33F26A1619, 33F26B1051, 33F25H0880; CDC-45703-PA1A/10801902193275, 30801902117190, 10801902117202/33F24M0081, 33F25F0241, 33F26A1656, 33F26B0334, 33F24C1072; ASK-42802-ECL4/10801902224283, 10801902205664/33F26B0489, 33F24D0651; AK-42703-P1A/10801902193275, 10801902171372/33F25D0323, 33F25D0585, 33F25F0122, 33F25F0153, 33F25G0376, 33F25J0135, 33F26B0459, 33F24L1104; AK-42802-P1A/10801902193275/33F25B0539, 33F25D0386, 33F25F0137, 33F25J0136, 33F25B0512; AK-42854-P1A/10801902193275, 10801902168167, 10801902119152/33F25E0664, 33F25H0442, 33F25J0341, 33F26B0752, 33F23H0557; AK-45703-P1A/10801902193275, 10801902171389/33F25C0341, 33F25D0387, 33F25D0643, 33F25F0154, 33F25G0257, 33F25G0375, 33F25J0137, 33F25J0342, 33F26A1416, 33F26B0150, 33F26B0766, 33F25C0191; AK-45802-P1A/10801902193275, 10801902168181/33F25E0665, 33F25J0191, 33F26B0754, 33F25A0223; AK-45854-P1A/10801902193275, 10801902168198/33F25D0459, 33F25F0138, 33F26B0145, 33F25B0540; AK-47702-P1A/10801902193275/33F25E0502, 33F25G0162, 33F25H0407, 33F25J0343, 33F24G0383; ASK-42703-PECL3/10801902193275/33F26A1397, 33F25B0562; ASK-42703-PUPM3/10801902225150, 10801902156966/33F26C0238, 33F24F0977; ASK-42802-PUPM3/10801902225143, 10801902193275/33F26C0239, 33F25B0498; ASK-45703-PECL3/10801902193275, 10801902224313/33F26A1577, 33F26B0773, 33F25C0234; ASK-45703-PUPM3/10801902225181, 10801902116465/33F26C0219, 33F24D0840; ASK-45854-PECL3/10801902193275/33F24L0191; ASK-45854-PUPM3/10801902225167, 10801902193275/33F26C0240, 33F24H0111; ASK-45854-SMW/10801902224436, 10801902214888/33F26B0830, 33F24F0872; CDC-42802-XP1A/10801902193275, 10801902168365, 10801902162103/33F25J0295, 33F25J0728, 33F25K0304, 33F25K0390, 33F25L0228, 33F25M0037, 33F25M0485, 33F25M0717, 33F26A1630, 36F25C0008, 36F25D0001, 36F25D0034, 36F25E0001, 36F25G0022, 36F25H0015, 33F24D0258; CDC-42854-XP1A/10801902193275, 20801902117148, 10801902162134/33F25J0681, 33F26A0390, 33F26C0209, 33F26D0062, 36F25D0003, 36F25H0014, 33F24D0827; CDC-45703-XP1A/10801902193275, 20801902117216/33F25G0286, 33F25H0876,33F25J0089,33F25J0682, 33F25J0702, 33F25J0705, 33F25J0711,33F25J0718, 33F25J0729, 33F25J0733, 33F25K0305, 33F25L0063,33F25L0093, 33F25L0094, 33F25L0231, 33F25L0252, 33F25L0253, 33F25L0254, 33F25L0286, 33F25L0302, 33F25L0322, 33F25M0487, 33F26A0062, 33F26B0637, 33F26B0638, 33F26D0185, 36F25A0008, 36F25A0014, 36F25D0010, 36F25D0011, 36F25D0014, 36F25D0021, 36F25D0022, 36F25D0023, 36F25D0028, 36F25D0041, 33F25C0372; CDC-45854-XP1A/10801902193275, 10801902169720, 10801902162158/33F25J0695, 33F25J0730, 33F25K0394, 33F26A1620, 33F26B0572, 33F26B0735, 36F25G0003, 36F25G0021, 36F25G0024, 36F25H0011, 36F25H0017, 33F24D0424 ASK-42703-PGM3/10801902213751/33F24F0951, 33F24K0743; ASK-42802-UH1/10801902156386/33F24H0122; ASK-45703-PGM3/10801902213768/33F24D0844, 33F24F0840;
Distribution pattern: 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.
Derived failure modes
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Unknown
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.