FDA Class II Recall: Brand Name: Kiwi Omni Vacuum Delivery System Product… by Clinical Innovations, LLC

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Clinical Innovations, LLC and the affected product is described in FDA's record as: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to complaints of device breakage at the traction force gauge to handle joint.. The recall is tracked under FDA recall number Z-1945-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device (additional items listed in FDA's full record) -- and the recall number Z-1945-2026. If it matches, stop using or distributing it and contact Clinical Innovations, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Clinical Innovations, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Clinical Innovations, LLC: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device (additional items listed in FDA's full record)) and.

Has Clinical Innovations, LLC had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Clinical Innovations, LLC so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number Z-1945-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions