openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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event_date_initiated coverage
June 01, 1997–June 30, 2026
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device · product 1 of 1
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
These labels are deterministic app interpretations, not FDA categories.
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
Code information
Lot Numbers: 39098746, 39655101, 39985370, 40067795
