Recall Z-0345-2016— DeRoyal Industries Inc

Name: FDA recall Z-0345-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-14

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2015-10-14, terminated 2017-07-01. It names one FDA 510(k) clearance: K925006. Product: HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.. 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..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Terminated: 2017-07-01
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K925006 — HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSODeroyal Industries, Inc.·cleared 1994-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.