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.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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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