Recall Z-2072-2020 ยท HDB Extractor, Vacuum, Fetal
Clinical Innovations, LLC
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
| Date | Aug 6, 2019 |
| Status | Terminated |
| 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 ha |
| Quantity | 2340 Units |
| Distribution | OUS customers only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc., Sep 22, 1998 |