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Use caution Medical device recall · FDA · Published August 6, 2019

Kiwi Complete Vacuum Delivery System Recall: Risk of Vacuum Failure During Fetal Delivery

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2072-2020Medical deviceClinical Innovations ›
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Contact the company

Recalling firmClinical Innovations, LLC747 W 4170 S · Murray, UT 84123-1364
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67255-kiwi-complete-vacuum-delivery-system-recall-risk-of-vacuum-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/67255-kiwi-complete-vacuum-delivery-system-recall-risk-of-vacuum-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2072-2020

Cite this page

“Kiwi Complete Vacuum Delivery System Recall: Risk of Vacuum Failure During Fetal Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67255-kiwi-complete-vacuum-delivery-system-recall-risk-of-vacuum-failure. Based on FDA recall #Z-2072-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2072-2020%22&limit=1).

The FDA announced on 2019-08-06 that Clinical Innovations, LLC voluntarily recalled the Kiwi Complete Vacuum Delivery System due to a potential loss of vacuum. The recall affects units distributed to OUS customers only.

How to tell if you have it

  • Brand: Clinical Innovations
  • Product: Kiwi Complete Vacuum Delivery System
  • Model No.: VAC-6000MTE
  • Lot no.: 181144
  • UDI: 00814247020659
  • Units affected: 2340

The hazard

According to the FDA, there is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

Context

GovInfoNow's records show Clinical Innovations, LLC has had five other recalls since 2019-05-30. Other recent recalls of similar products include Medline C-Section Prep Kits Recall (2026-06-12), AVID Medical Halyard Transport Bag Kit Recall (2026-01-02), and Olympus UHI-4 Insufflation Unit Recall (2026-06-16).

How to tell if you have this one

Check for the model number VAC-6000MTE on the device. The product was sold with lot number 181144 and UDI 00814247020659.

  • Brand
    Clinical Innovations
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number VAC-6000MTE on the Kiwi Complete Vacuum Delivery System.

  2. Contact Manufacturer

    Reach out to Clinical Innovations for guidance on next steps if you have the recalled model.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Aug 6, 201912. FDA classified it Class II: May 21, 202023. Published in FDA’s Enforcement Report: May 27, 202034. FDA terminated the recall: Sep 16, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2072-2020 (August 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2072-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA