FDA Medical Device Recalls (openFDA)
Clinical Innovations, LLC: Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
- Recall number
- Z-2072-2020
- Recalling firm
- Clinical Innovations, LLC
- Product
- Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
- Status
- Terminated
- Initiated
- 2019-08-06
- Posted
- not on file
- Terminated
- 2022-09-16
- Reason
- There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
- Root cause
- Process control
- Action
- Clinical Innovations sent Field Safety Notice Letters to their distributors via email on July 2, 2019. The letter notified distributors that the firm had received reports of Kiwi devices that fail to generate or maintain vacuum during use. Distributors were informed that Clinical Innovations conducted an investigation on the returned devices and concluded that these are associated with a manufacturing nonconformity caused by not applying enough solvent during the production process. The Field Safety Notice Letters also noted that Clinical Innovations had not received any reports of patient harm associated with Lot 181144. Distributors were requested to provide this information to their hospitals, and, if hospitals had further distributed this product, to, in turn, identify their customers and notify them at once of this communication and/or contact Clinical Innovations with the contact information so that the firm could follow-up with the owner of the device. Customers were instructed to quarantine any remaining product in their hospitals and complete the response card attached to the Field Safety Notice. Customers were informed that a company representative would contact them and arrange for the return of the product. Customers were instructed to contact Clinical Innovations, at +{33) 383 22 20 76 M-F 8:00AM- 5 PM GMT+2 or 1-{888)- 268-6222 M-F 8:00AM-5:00PM MT or their Clinical Innovation's service representative with any questions.
- Quantity
- 2340 Units
- Distribution
- OUS customers only.
- Lot, serial or model codes
- Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659
- 510(k) numbers
- ["K981260"]
- PMA numbers
- not on file
- Product code
- HDB
- Firm FEI
- 1000220650
- Firm city
- Murray
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28