Clinical Innovations recalls Kiwi Complete Vacuum Delivery System Model VAC-6000MTE due to potential vacuum loss or failure during fetal delivery, which could affect safe use.
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Clinical Innovations recalls its Kiwi Complete Vacuum Delivery System (Model VAC-6000MTE) because it may lose vacuum or fail to generate vacuum during fetal delivery. This could lead to unsafe use of the device in medical procedures.
The device may lose vacuum or fail to generate vacuum during fetal delivery procedures. This could result in improper delivery of the fetus or complications requiring immediate medical intervention.
Healthcare providers using the Kiwi system for fetal delivery are most at risk. The recall affects medical devices used in obstetric settings.
Check for the model number VAC-6000MTE on the device. The product was sold with lot number 181144 and UDI 00814247020659.
Look for the model number VAC-6000MTE on the Kiwi Complete Vacuum Delivery System.
Reach out to Clinical Innovations for guidance on next steps if you have the recalled model.
The recall indicates a potential risk of vacuum failure during fetal delivery, so it is not recommended for use until the manufacturer provides guidance.
Check the model number and contact Clinical Innovations for specific instructions.
Look for the model number VAC-6000MTE, lot number 181144, or UDI 00814247020659 on the device.
We’ve drafted a message you can send Clinical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-2072-2020 — Clinical Innovations Clinical Innovations Hello, I own a Clinical Innovations that is covered by recall Z-2072-2020 from Clinical Innovations. 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.
