Home / Recalls / WEST PHARMA. SERVICES IL, LTD / Z-0768-2019

Z-0768-2019 Class I Terminated

Recalled by WEST PHARMA. SERVICES IL, LTD — Ra'Anana, N/A

Recall Details

Product Type
Devices
Report Date
February 6, 2019
Initiation Date
December 26, 2018
Termination Date
July 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4.9 million units

Product Description

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

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.

Distribution Pattern

US Distributor in MO

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

Other recalls by WEST PHARMA. SERVICES IL, LTD

  • Z-0769-2019 Class I — Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only (December 26, 2018)
  • Z-0767-2019 Class I — Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only (December 26, 2018)