FDA-Device2015-12-09Class II
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
DeRoyal Industries Inc
Hazard
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.
Sold states
Distributed in the states of VA, AL, FL, and CA.
Affected count
16 cases of 50 units (800 eaches)
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0345-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief