Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a medical device with a documented mechanical failure (traction force gauge breakage). No reported injuries or illnesses are mentioned in the source text. The hazard involves potential loss of device functionality during use rather than direct harm from the product itself, placing it at Moderate severity.
Plain-English summary
Clinical Innovations, LLC is recalling the Kiwi Omni Vacuum Delivery System, Model VAC-6000MT, a disposable vacuum-assisted fetal delivery device. The recall is due to complaints of device breakage at the traction force gauge to handle joint.
The affected devices were distributed nationwide across multiple U.S. states and internationally to Canada, China, Japan, Czech Republic, and Singapore. A total of 49,175 devices are involved in this recall. The affected lot codes are: 251327, 251333, 251328, 251330, 251370, 251388, 251545, 251546, 251582, 251583, 251680, and 251681 (Model/Catalog Number VAC-6000MT, UDI: 00814247020642).
Clinicians who have inventory of this device should discontinue use of affected lots. Healthcare providers should verify the lot code on their devices and check the FDA's recall notice for additional instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Clinical Innovations, LLC
- Affected units
- 49,175
Distribution
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