West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices
West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model 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) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
West Pharma Services IL, Ltd is recalling Vial2BAG DC 20mm devices (REF 6070112 & 6070112C). 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 20mm device is being recalled due to similarities with the 13mm model.
The affected products are single-use, prescription-only devices. The recall covers 30 million units distributed to a US distributor in Missouri. The source text does not specify the exact nature of the adverse events or the number of affected patients.
Consumers and healthcare providers should stop using the recalled devices and contact West Pharma Services for further instructions.
The recalled product
- Product
- Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
- Manufacturer
- WEST PHARMA. SERVICES IL, LTD
- Affected units
- 30
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 (20)
- 7690
- 7750
- 7751
- 7865
- 7866
- 7867
- 7868
- 7886
- 7887
- 7888
- 7900
- 7901
- 7902
- 7957
- 7958
- 7959
- 7960
- 7949
- 7951
- 7952
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.
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