Z-2829-2016Class II

AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of...

Name: Z-2829-2016 AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of...
Creator: AirStrip Technologies, Inc.
Published: 2016-08-04
License: https://open.fda.gov/license/

AirStrip Technologies, Inc. / initiated 2016-08-04 / Terminated / root cause: manufacturing process

FDA source

AirStrip Technologies, Inc. began a recall of AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the... on 2016-08-04. FDA classified it as Class II and gives the reason as "Belt clip may become detached causing electronic components to be exposed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2829-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Posted: 2016-09-15
Terminated: 2016-11-30
Recalling firm: AirStrip Technologies, Inc.
Product: 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.
Product code: LQK Home Uterine Activity Monitor
Reason for recall: Belt clip may become detached causing electronic components to be exposed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 42
Distribution: U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2829-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2829-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15

Product code LQK

K143114Class IISense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. / cleared 2015-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)