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

Recall date

October 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0345-2016

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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