Product Wiki · Recalls · U.S. FDA — Device Enforcement

Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. — recall Z-2072-2020

U.S. FDA — Device Enforcement · United States · 2019-08-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2072-2020
Date of alert
2019-08-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Clinical Innovations, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00814247020659
Reported risk: There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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