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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96094

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

Open FDA event record

Event summary

Timeline bucket
December 26, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
ROi CPS 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

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Z-1047-2025
Recall number
Z-1047-2025
Initiated
December 26, 2024
Classification
Class I
Status
Ongoing
Recalling firm
ROi CPS LLC
Quantity
414 kits

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

Code information

Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486.

Distribution pattern

Distribution was made to MO. There was no government/military/foreign distribution.