Clinical Innovations Recalls Kiwi Vacuum Delivery System Due to Vacuum Failure
Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System because the device may fail to generate or maintain vacuum during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure of a medical device used in a high-risk procedure (fetal delivery), representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE. The recall involves a specific lot (lot no. 181144) with UDI 00814247020659. The product is a disposable vacuum-assisted fetal delivery system.
The recall was initiated because there is a potential for loss of vacuum or failure to generate vacuum when using the system. This defect could compromise the intended function of the device during fetal delivery.
The affected units were distributed to OUS customers only. Healthcare providers and facilities should stop using the recalled product and contact Clinical Innovations, LLC for further instructions on return or replacement.
The recalled product
- Product
- Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
- Manufacturer
- Clinical Innovations, LLC
- Affected units
- 2,340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. VAC-6000MTE
- lot no. 181144
- UDI: 00814247020659
Distribution
Distribution scope not specified by the agency.
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