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 |
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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.
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510(K) Database | 510(K)s with Product Code = LQK
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