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U.S. Department of Health and Human Services

Class 2 Device Recall AirStrip Sense4Baby Model C Fetal Monitor

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  Class 2 Device Recall AirStrip Sense4Baby Model C Fetal Monitor see related information
Date Initiated by Firm August 04, 2016
Date Posted September 15, 2016
Recall Status1 Terminated 3 on November 30, 2016
Recall Number Z-2829-2016
Recall Event ID 74963
510(K)Number K143114  
Product Classification Home uterine activity monitor - Product Code LQK
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.
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
Recalling Firm/
Manufacturer		 AirStrip Technologies, Inc.
565 Pearl St Ste 209
La Jolla CA 92037-5050
For Additional Information Contact
210-805-0444
Manufacturer Reason
for Recall		 Belt clip may become detached causing electronic components to be exposed.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LQK and Original Applicant = AIRSTRIP TECHNOLOGIES, INC.
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