Device product
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Z-0769-2019
Product summary
- Event
- Event 81877
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30 million units
- Official record key
device-enforcement:Z-0769-2019
Official wording
Reason: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.
Code information: 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
Distribution pattern: US Distributor in MO
Derived failure modes
-
Unknown
Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.