Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0768-2019

December 26, 2018

Class I

Product summary

Firm
WEST PHARMA. SERVICES IL, LTD
Event
Event 81877
Status
Terminated
Classification
Class I
Quantity
4.9 million units
Official record key
device-enforcement:Z-0768-2019

Official wording

Reason: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag 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

Derived failure modes

  • 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.