Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 6, 2019
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
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 V…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
West Pharma. Services Il, LTD recalled Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only - a critical-severity action.
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only was recalled by West Pharma. Services Il, LTD in February 6, 2019. Reason: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregna…. Check the official notice for the remedy. Verify recall #Z-0769-2019 with the FDA Devices before acting.
The recall
West Pharma. Services Il, LTD issued this critical-severity FDA Devices recall-Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregna….
- Critical
- severity level
- Class I
- classification
- February 6, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0769-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0769-2019) was formally reported on February 6, 2019, with the manufacturer initiating the action on December 26, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. West Pharma. Services Il, LTD is listed as the recalling firm, operating out of Ra'Anana, N/A. Federal records list the affected scope as 30 million units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: US Distributor in MO. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
30 million units
Related Recalls
6
0 from same agency
Product description
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, 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 DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0769-2019 |
| Date reported | February 6, 2019 |
| Date initiated | December 26, 2018 |
| Recalling firm | West Pharma. Services Il, LTD |
| Firm location | Ra'Anana, N/A |
| Affected scope | 30 million units |
| Distribution | US Distributor in MO |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0769-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only. Recalled by West Pharma. Services Il, LTD. Units affected: 30 million units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2019. Severity: Critical. Recall number: Z-0769-2019.
Where was the recalled product distributed? ▼
Distribution: US Distributor in MO.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0769-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.