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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

WEST PHARMA. SERVICES IL, LTD: Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.; Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled due to similarities with 1

Agency Publication Date: January 28, 2019
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Affected Products

Product: Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

UDI: (01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111 Lot Numbers: 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9175, 9029, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9656, 9655, 9918, 9710, 9711, 9712, 9713, 9839, 9840, 9983, 9984, 9992, 9993, 9994, 9995, A123, A124, A790, A805, A806, A791, A792, A793, A794, A795, A796, A797, A807, A808, A809, A810, A834, A835, A836, A837, A838 & A839

Lot Numbers:
Numbers
Product: Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

UDI: (01)07290108240047(17)190301(10)7885(90)36098093(91)6070104 Lot Numbers: 7885, 7889, 7889, 8300, 8391, 8646, 8788, 8950, 9038, 9039, 9166, 9167, 9669, 9682, 9982, A672, C063, C070

Lot Numbers:
Numbers
Product: Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only

UDI: (01)07290108240054(17)190101(10)7689(90)36098126(91)6070112 Lot Numbers: 7689, 7690, 7750, 7751, 7865, 7866, 7867, 7868, 7886, 7887, 7888, 7900, 7901, 7902, 7957, 7958, 7959, 7960, 7949, 7951, 7952, 7954, 8019, 8020, 8021, 8022, 8132, 8133, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8141, 8142, 8143, 8144, 8145, 8147, 8148, 8149, 8150, 8151, 8470, 8471, 8472, 8473, 8483, 8696, 8553, 8554, 8555, 8556, 8557, 8558, 8559, 8560, 8561, 8562, 8563, 8564, 8565, 8566, 8567, 8568, 8569, 8570, 8571, 8760, 8761, 8762, 8763, 8764, 8765, 8766, 8767, 8768, 8769, 8770, 8771, 8772, 8887, 8888, 8889, 8890, 8891, 8892, 8893, 8894, 8895, 9040, 9041, 9042, 9042, 9043, 9044, 9045, 9046, 9047, 9169, 9170, 9171, 9172, 9173, 9174, 9271, 9272, 9273, 9274, 9275, 9276, 9277, 9278, 9323, 9324, 9325, 9326, 9327, 9328, 9329, 9330, 9394, 9500, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9537, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9810, 9841, 9842, 9843, 9844, 9845, 9846, 9847, 9848, 9849, 9964, 9965, 9966, 9967, 9968, 9969, 9970, 9971, 9972, 9973, 9974, 9975, 9976, 9978, 9979, 9980, A018, A019, A001, A002, A003, A004, A005, A020, A021, A022, A023, A024, A025, A026, A027, A028, A029, A030, A031, A032, A033, A034, A006, A007, A008, A009, A010, A011, A012, A013, A014, A015, A016, A017, A106, A107, A108, A109, A110, A111, A258, A112, A113, A114, A115, A116, A117, A118, A119, A120, A121, A122, A254, A321, A322, A323, A330, A343, A344, A345, A346, A347, A348, A349, A350, A351, A352, A353, A354, A355, A324, A325, A326, A327, A328, A329, A331, A332, A333, A334, A335, A336, A337, A356, A357, A358, A359, A360, A361, A362, A338, A339, A340, A519, A520, A521, A522, A523, A524, A525, A526, A527, A528, A529, A530, A530, A531, A532, A533, A534, A535, A536, A537, A538, A539, A540, A541, A542, A543, A544, A545, A546, A547, A548, A549, A550, A551, A552, A553, A554, A555, A556, A557, A558, A559, A560, A561, A562, A563, A564, A565, A566, A568, A569, A570, A571, A572, A567, A573, A574, A575, A576, A577, A578, A579, A580, A581, A582, A817, A819, A813, A814, A815, A816, A818, A820, A821, A822, A823, A824, A825, A826, A840, A840, A841, A842, A843, A843, A845, A844, A898, A899, A900, A901, A902, A903, A904, A905, A906, A907, A908, A909, A910, A911, A915, A916, A917, A918, A919, A920, A921, A982, A983, A984, A985, A986, A987, A988, C015, C016, C017, C017, C033, C034, C035, C036, C037, C038, C039, C040, C041, C042, C043, C044, C045, C046, C047, C048, C049, C050, C051, C052, C053, C054, C055 & C056 UDI: (01)07290108241006(17)190501(10)8344(90)36098138(91)6070112C Lot Number: 8344

Lot Numbers:
Numbers
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81877
Status: Resolved
Manufacturer: WEST PHARMA. SERVICES IL, LTD
Manufactured In: Israel
Units Affected: 3 products (3.9 million units; 4.9 million units; 30 million units)
Agency Last Updated: February 6, 2019

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.