Kiwi Complete Vacuum Delivery System recall
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Why was Kiwi Complete Vacuum Delivery System recalled?
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659
- Product
- Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
- Recalling firm
- Clinical Innovations, LLC
- Quantity
- 2340 Units
- Distribution
- OUS customers only.
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)