West Pharma Vial2BAG DC 13mm Recalled for Adverse Events
West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
West Pharma Services IL, Ltd. is recalling approximately 3.9 million units of Vial2BAG DC 13mm (REF 6070111). The product is a single-use, prescription-only medical device distributed to a US distributor in Missouri.
The recall was initiated because adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. The device may cause inadequate admixing of the drug with the solution in the IV bag, which could lead to concentrated drug pooling in the device and bolus injections.
Consumers and healthcare providers should stop using the affected units and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Vial2BAG DC 13mm, REF 6070111, 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 (20)
- 7154
- 7634
- 7688
- 7752
- 7909
- 7955
- 8152
- 8153
- 8154
- 8232
- 8233
- 8234
- 8235
- 9028
- 9175
- 9029
- 9176
- 9177
- 9178
- 9367
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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