WEST PHARMA. SERVICES IL, LTD: Medical Device Recall in 2019 - (Recall #: Z-0767-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: December 26, 2018

Date Posted: February 6, 2019

Recall Number: Z-0767-2019

Event ID: 81877

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.

Status: Terminated

Product Quantity: 3.9 million units

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

Voluntary or Mandated:

Voluntary: Firm initiated