FDAClass IFebruary 6, 2019

Vial2BAG Transfer Device recall

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

Why was Vial2BAG Transfer Device recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
Recalling firm
WEST PHARMA. SERVICES IL, LTD
Quantity
4.9 million units
Distribution
US Distributor in MO
Recall date
February 6, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls