Reported Feb 6, 2019 · Terminated
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
West Pharma. Services Il, Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WEST PHARMA. SERVICES IL, LTD · 4, Ha-Sheizaf · Ra'Anana, N/A · N/A
Is this the product you have?
- Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
- Lot codes and dates
- UDI(01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111
- Lot Numbers
61 of 61 codes
7153715476347688775279097955815281538154823282338234823590289175902991769177917893679368936993709654965696559918971097119712971398399840998399849992999399949995A123A124A790A805A806A791A792A793A794A795A796A797A807A808A809A810A834A835A836A837
- Amount recalled
- 3.9 million units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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