Home / Recalls / Clinical Innovations, LLC / Z-2072-2020

Z-2072-2020 Class II Terminated

Recalled by Clinical Innovations, LLC — Murray, UT

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
August 6, 2019
Termination Date
September 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2340 Units

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.

Distribution Pattern

OUS customers only.

Code Information

Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659

Other recalls by Clinical Innovations, LLC

  • F-1682-2022 Class II — Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each b (July 19, 2022)
  • F-1684-2022 Class II — Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of (July 19, 2022)
  • F-1685-2022 Class II — Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of (July 19, 2022)
  • Z-0541-2021 Class II — Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membra (August 13, 2020)
  • Z-2118-2020 Class II — Clearview Total Uterine Manipulator (model UM750), The device is labeled in par (May 30, 2019)
  • Z-0123-2016 Class II — The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for (January 5, 2015)
  • Z-1014-2015 Class II — Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, (December 30, 2014)