Recall Z-2072-2020— Clinical Innovations, LLC

Name: FDA recall Z-2072-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-06

Class II · Terminated

Class II FDA medical device recall by Clinical Innovations, LLC, initiated 2019-08-06, terminated 2022-09-16. It names one FDA 510(k) clearance: K981260. Product: Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.. Reason: There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system..

Recalling firm: Clinical Innovations, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Terminated: 2022-09-16
Firm location: Murray, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MClinical Innovations, Inc.·cleared 1998-09-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.