Drug recall
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA recall event 81877 · Class I · WEST PHARMA. SERVICES IL, LTD
Key facts
| Event ID | 81877 |
|---|---|
| Recall numbers | Z-0767-2019, Z-0768-2019, Z-0769-2019 |
| Recalling firm | WEST PHARMA. SERVICES IL, LTD |
| Product type | Devices |
| Products | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only, Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only, Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC., 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., Adverse events have been… |
| Initiation date | Dec 26, 2018 |
| Report date | Feb 6, 2019 |
| Termination date | Jul 20, 2022 |
| City | Ra'Anana |
| Country | Israel |
| FEI number | 3014150230 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: