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U.S. Department of Health and Human Services

Class 2 Device Recall HYDROTEMP(R) Neonatal Temperature Skin Sensor

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 Class 2 Device Recall HYDROTEMP(R) Neonatal Temperature Skin Sensorsee related information
Date Initiated by FirmOctober 14, 2015
Date PostedNovember 30, 2015
Recall Status1 Terminated 3 on July 01, 2017
Recall NumberZ-0345-2016
Recall Event ID 72454
510(K)NumberK925006 
Product Classification Warmer, infant radiant - Product Code FMT
ProductHYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
Code Information Lot Numbers: 39098746, 39655101, 39985370, 40067795
FEI Number 1043214
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactWilliam G. Pittman
865-362-2901
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionDeRoyal 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 in Commerce16 cases of 50 units (800 eaches)
DistributionDistributed in the states of VA, AL, FL, and CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMT
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