Data Foundry

Medical device recalls 2019

Vial2BAG Transfer Device — Class I medical device recall Z-0768-2019

Terminated recall by WEST PHARMA. SERVICES IL, LTD, reported 2019-02-06. Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnan

Recall numberZ-0768-2019
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmWEST PHARMA. SERVICES IL, LTD, Ra'Anana, N/A, Israel
Recall initiated2018-12-26
Classified2019-01-28
Reported by FDA2019-02-06
Terminated2022-07-20
Quantity4.9 million
UPC / GTIN / UDI-DI07290108240047
Lot numbers7885, 7889, 8300, 8391, 8646, 8788, 8950, 9038, 9039, 9166, 9167, 9669, 9682, 9982, A672, C063, C070
Model numbers6070104

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0768-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.