Date Initiated by Firm |
October 14, 2015 |
Date Posted |
November 30, 2015 |
Recall Status1 |
Terminated 3 on July 01, 2017 |
Recall Number |
Z-0345-2016 |
Recall Event ID |
72454 |
510(K)Number |
K925006
|
Product Classification |
Warmer, infant radiant - Product Code FMT
|
Product |
HYDRO-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 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
|
For Additional Information Contact |
William 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 |
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 in Commerce |
16 cases of 50 units (800 eaches) |
Distribution |
Distributed in the states of VA, AL, FL, and CA. |
Total Product Life Cycle |
TPLC Device Report
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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) Database |
510(K)s with Product Code = FMT and Original Applicant = DEROYAL INDUSTRIES, INC.
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