Exact FDA event identifier

Event 85170

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 06, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Clinical Innovations, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2072-2020

Recall number: Z-2072-2020
Initiated: August 06, 2019
Classification: Class II
Status: Terminated
Recalling firm: Clinical Innovations, LLC
Quantity: 2340 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

OUS customers only.