Events

Recall of AirStrip Sense4Baby Model C Fetal Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AirStrip Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74963
  • Event Risk Class
    Class 2
  • Event Number
    Z-2829-2016
  • Event Initiated Date
    2016-08-04
  • Event Date Posted
    2016-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148904
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Home uterine activity monitor - Product Code LQK
  • Reason
    Belt clip may become detached causing electronic components to be exposed.
  • Action
    The firm sent out customer notification letters on August 4, 2016. Customers were instructed to cease distribution and use of the device and notify any customers in possession of it. Customers were informed that Airstrip would make arrangements to return the affected Central Units to AirStrip for correction at AirStrips expense. If customers have not been contacted by AirStrip to make these arrangements call AirStrip tollfree at 1 (877) 258-5869. For further questions, please call (210) 805-0444.

Device

AirStrip Sense4Baby Model C Fetal Monitor
  • Model / Serial
    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
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
  • Product Description
    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.
  • Manufacturer
    AirStrip Technologies, Inc.

Manufacturer

AirStrip Technologies, Inc.
  • Manufacturer Address
    AirStrip Technologies, Inc., 565 Pearl St Ste 209, La Jolla CA 92037-5050
  • Manufacturer Parent Company (2017)
    AirStrip Technologies Inc.
  • Source
    USFDA