Recall Z-0345-2016 ยท FMT Warmer, Infant Radiant
DeRoyal Industries Inc
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
| Date | Nov 30, 2015 (initiated Oct 14, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925006 | HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO Deroyal Industries, Inc., Jan 31, 1994 |