Device recall: Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
WEST PHARMA. SERVICES IL, LTD (Ra'Anana, N/A) initiated this device recall on 26 Dec 2018; FDA lists 3 product records under event 81877, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 20 Jul 2022. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for WEST PHARMA. SERVICES IL, LTD.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
WEST PHARMA. SERVICES IL, LTD, Ra'Anana, N/A, Israel.
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."
Distribution
"US Distributor in MO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0767-2019 | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only | 3.9 million units | Class I | Terminated | 6 Feb 2019 |
| Z-0768-2019 | Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only | 4.9 million units | Class I | Terminated | 6 Feb 2019 |
| Z-0769-2019 | Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only | 30 million units | Class I | Terminated | 6 Feb 2019 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distributor in MO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Jul 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.