FDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events
West Pharma Services is recalling Vial2BAG Transfer Devices because adverse events were reported when used with oxytocin in pregnant women.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported adverse events in a high-risk population (pregnant women), but the source does not specify FDA Class I or report fatalities, placing it in the High category for risk-of-harm products.
Plain-English summary
West Pharma Services IL, Ltd is recalling the Vial2BAG Transfer Device, REF 6070104. The recall involves approximately 4.9 million units of the single-use, prescription-only device. The product was distributed through a US distributor in Missouri.
The recall is being conducted because adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. The Vial2BAG Transfer Device is being recalled due to similarities with the 13mm Vial2Bag DC.
Healthcare providers and facilities should stop using the affected Vial2BAG Transfer Devices and contact the recalling firm for instructions on how to return or dispose of the product. Consumers should not use the device and should contact their healthcare provider if they have questions.
The recalled product
- Product
- Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
- Manufacturer
- WEST PHARMA. SERVICES IL, LTD
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 7889
- 8300
- 8391
- 8646
- 8788
- 8950
- 9038
- 9039
- 9166
- 9167
- 9669
- 9682
- 9982
- A672
- C063
- C070
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by WEST PHARMA. SERVICES IL, LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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