FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
- Recall number
- Z-0345-2016
- Recalling firm
- DeRoyal Industries Inc
- Product
- HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
- Status
- Terminated
- Initiated
- 2015-10-14
- Posted
- 2015-11-30
- Terminated
- 2017-07-01
- 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.
- 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
- 16 cases of 50 units (800 eaches)
- Distribution
- Distributed in the states of VA, AL, FL, and CA.
- Lot, serial or model codes
- Lot Numbers: 39098746, 39655101, 39985370, 40067795
- 510(k) numbers
- ["K925006"]
- PMA numbers
- not on file
- Product code
- FMT
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28