Class II — AirStrip Technologies, Inc.
| Recalling firm | AirStrip Technologies |
|---|---|
| Registered facility | AirStrip Technologies, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Belt clip may become detached causing electronic components to be exposed. |
| 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. |
| Quantity | 42 |
| Distribution | U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands. |
| Initiated | 2016-08-04 |
| Classified | 2016-09-15 |
| Terminated | 2016-11-30 |
| Recall number | Z-2829-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AirStrip Technologies, Inc. (Z-2829-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74963/
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