—#141078

Product

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

FDA product code: FMT — Warmer, Infant Radiant
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K925006
Affected lot / code info: Lot Numbers: 39098746, 39655101, 39985370, 40067795

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Distributed in the states of VA, AL, FL, and CA.

Timeline

Recall initiated: 2015-10-14
Posted by FDA: 2015-11-30
Terminated: 2017-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.