Recall Z-2829-2016 ยท LQK Home Uterine Activity Monitor
AirStrip Technologies, Inc.
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
| Date | Sep 15, 2016 (initiated Aug 4, 2016) |
| Status | Terminated |
| Reason | Belt clip may become detached causing electronic components to be exposed. |
| 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 | 42 |
| Distribution | U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143114 | Sense4Baby System Model B+ (MSA) Airstrip Technologies, Inc., Mar 10, 2015 |