HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
FDA Recall Z-0345-2016 · Posted 2015-11-30
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Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeFMT
Date Initiated2015-10-14
Date Terminated2017-07-01
Product Quantity16 cases of 50 units (800 eaches)
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 port, this defect results in the inability to read or display temperatures on the infant warming system.
Firm 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.
Root Cause
Process control
Distribution Pattern
Distributed in the states of VA, AL, FL, and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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