Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Recall #Z-0768-2019 — Class I — December 26, 2018
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.
Recalling Firm
WEST PHARMA. SERVICES IL, LTD — Ra'Anana, N/A
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
4.9 million units
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated