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.
FDA Recall Z-2829-2016 · Posted 2016-09-15
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Recalling FirmAirStrip Technologies, Inc.
Recall StatusTerminated
Product CodeLQK
Date Initiated2016-08-04
Date Terminated2016-11-30
Product Quantity42
Reason for Recall
Belt clip may become detached causing electronic components to be exposed.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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