Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

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.