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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81877

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 26, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
WEST PHARMA. SERVICES IL, LTD

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-0767-2019
Recall number
Z-0767-2019
Initiated
December 26, 2018
Classification
Class I
Status
Terminated
Quantity
3.9 million units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Distributor in MO

device · product 2 of 3

Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

Z-0768-2019
Recall number
Z-0768-2019
Initiated
December 26, 2018
Classification
Class I
Status
Terminated
Quantity
4.9 million units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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 13mm Vial2Bag DC.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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 13mm Vial2Bag DC.

Code information

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

Distribution pattern

US Distributor in MO

device · product 3 of 3

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

Z-0769-2019
Recall number
Z-0769-2019
Initiated
December 26, 2018
Classification
Class I
Status
Terminated
Quantity
30 million units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Field note

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