West Pharma Services recalls Vial2BAG DC 13mm (REF 6070111) due to potential inadequate mixing of oxytocin with IV solution, which could cause concentrated drug pooling and bolus injections in pregnant women.
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.
West Pharma Services is recalling Vial2BAG DC 13mm IV bags (REF 6070111) because they may not mix oxytocin properly with IV solution. This could lead to concentrated drug pooling and risky bolus injections in pregnant women.
The device may not mix oxytocin with IV solution properly, causing concentrated drug pooling. This could lead to bolus injections (rapid, high-dose delivery) that might harm pregnant women.
Pregnant women using this IV bag for oxytocin treatment are most at risk. Healthcare providers who administer oxytocin via this device may also be affected.
Check for the product name 'Vial2BAG DC 13mm', reference number 6070111, and lot numbers listed in the recall (e.g., 7153, 7154, 7634, etc.). This product is prescription-only and sold under the brand name West Pharma.
Identify the reference number (6070111) and lot numbers (e.g., 7153, 7154) to confirm if your device is recalled.
Talk to your doctor or pharmacist about whether you need to stop using this device immediately or switch to a safer alternative.
The recall states there is a possibility of inadequate mixing, which could cause concentrated drug pooling. It is not safe for pregnant women using this device.
Lot numbers 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9175, 9029, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9656, 9655, 9918, 9710, 9711, 9712, 9713, 9839, 9840, 9983, 9984, 9992, 9993, 9994, 9995, A123, A124, A790, A805, A806, A791, A792, A793, A794, A795, A796, A797, A807, A808, A809, A810, A834, A835, A836, A837, A838, and A839 are affected.
The recall does not specify an immediate stop; it says there is a possibility of inadequate mixing. Contact your healthcare provider for guidance.
We’ve drafted a message you can send West Pharma Services to request your refund or repair — edit it as you like.
Subject: Recall Z-0767-2019 — West Pharma Services West Pharma Services Hello, I own a West Pharma Services that is covered by recall Z-0767-2019 from West Pharma Services. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
