Z-0345-2016Class II

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

Name: Z-0345-2016 HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only
Creator: DeRoyal Industries Inc
Published: 2015-10-14
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2015-10-14 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only on 2015-10-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0345-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-30
Terminated: 2017-07-01
Recalling firm: DeRoyal Industries, Inc.
Product: HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
Product code: FMT Warmer, Infant Radiant
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal issued their recall on 10/14/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. The consignees were instructed to destroy and discard the units. In the case of further distribution, the firm requested that the consignee either notify its customers of the recall or to submit a customer list for DeRoyal to contact them.
Quantity in commerce: 16 cases of 50 units (800 eaches)
Distribution: Distributed in the states of VA, AL, FL, and CA.
Product codes and lots: Lot Numbers: 39098746, 39655101, 39985370, 40067795

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0345-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0345-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-11-30

Product code FMT

K925006Class IIHydro-Temp NICU and Skin Surface Temperature SensoDeroyal Industries, Inc. / cleared 1994-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)