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Recall Observatory FDA recall evidence

Device product

HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.

Z-0345-2016

October 14, 2015

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 72454
Status
Terminated
Classification
Class II
Quantity
16 cases of 50 units (800 eaches)
Official record key
device-enforcement:Z-0345-2016

Official wording

Reason: 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

Distribution pattern: Distributed in the states of VA, AL, FL, and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.