Drug recall
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
FDA recall event 72454 · Class II · DeRoyal Industries Inc
Key facts
| Event ID | 72454 |
|---|---|
| Recall numbers | Z-0345-2016 |
| Recalling firm | DeRoyal Industries Inc |
| Product type | Devices |
| Products | HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 14, 2015 |
| Report date | Dec 9, 2015 |
| Termination date | Jul 1, 2017 |
| City | Powell |
| State | TN |
| Country | United States |
| FEI number | 1043214 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: