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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74963

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

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Event summary

Timeline bucket
August 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AirStrip Technologies, Inc.

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

AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.

Z-2829-2016
Recall number
Z-2829-2016
Initiated
August 04, 2016
Classification
Class II
Status
Terminated
Quantity
42

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Belt clip may become detached causing electronic components to be exposed.

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

Belt clip may become detached causing electronic components to be exposed.

Code information

Serial Number: C2386DA70E C2386EC9CD C2386ECAF3 C2386EC9CE C2386EC9B6 C2386EC9C5 C2386EC9C0 C2386EC9CB C2386DA70D C2386EC9AF C2386EC9B7 C2386EC9CF C2386EC9B4 C2386DA718 C2386ECAF5 C2386EC9B5 C2387684D9 C2386DA771 C2386EC9B8 C2386EC9D4 C2386EC9C3 C2386EC9B3 C2386ECAFA C2386EC4C4 C2386EC9C9 C2386EC9D3 C2386ECAE6 C2386DA77E C2386EC9B1 C2386DA715 C2386EC9CE C2386EC9BC C2386ECB36 C2386EC9C1 C2386EC9DC C2386ECAF8 C2386DA786 C2386ECAFB C2386EC9AE C2386EC9C8 C2386EC9D0 C2386ECAEE

Distribution pattern

U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.