DeRoyal Recalls Neonatal Temperature Skin Sensors Due to Soldering Defect
DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for neonatal monitoring where a defect prevents temperature readings. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DeRoyal Industries Inc is recalling four lots of HYDRO-TEMP(R) Neonatal Temperature Skin Sensors, REF HNICU-32. The recall involves 16 cases containing 800 individual units. The affected products were distributed in Virginia, Alabama, Florida, and California. The specific lot numbers are 39098746, 39655101, 39985370, and 40067795.
The recall was initiated because the pins in the sensor probes were soldered incorrectly. When the defective probe is connected to the proper port on an infant warming system, the device is unable to read or display temperatures. This defect compromises the functionality of the monitoring equipment used for neonatal care.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If you possess these units, they should be removed from service and returned to DeRoyal Industries Inc according to the company's instructions. The product is classified as a Class II recall by the FDA.
The recalled product
- Product
- HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
- Manufacturer
- DeRoyal Industries Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 39098746
- 39655101
- 39985370
- 40067795
Distribution
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