Reported Sep 21, 2016 · Terminated

AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and…

AirStrip Technologies, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AirStrip Technologies, Inc. · 565 Pearl St Ste 209 · La Jolla, CA · 92037-5050

Is this the product you have?

  • 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.
Lot codes and dates
  • Serial NumberC2386DA70E 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
Amount recalled
42

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 30, 2016 · Data as of Sep 19, 5:18 PM UTC

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