AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and feta
FDA device recall Z-2829-2016 · posted 2016-09-15 · Terminated
Recall details
- Recalling firm
- AirStrip Technologies, Inc.
- Reason for recall
- Belt clip may become detached causing electronic components to be exposed.
- Action taken
- 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
- Status
- Terminated
- Product code
- LQK
- Quantity affected
- 42
- Distribution
- U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
- Date initiated
- 2016-08-04
- Date posted
- 2016-09-15
- Date terminated
- 2016-11-30
- Location
- La Jolla, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sense4Baby System Model B+ (MSA) (K143114) | Airstrip Technologies, Inc. | 2015-03-10 |