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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Cardiac Hypothermia Tray

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  Class 2 Device Recall DeRoyal Cardiac Hypothermia Tray see related information
Date Initiated by Firm June 04, 2014
Date Posted July 29, 2014
Recall Status1 Terminated 3 on May 05, 2015
Recall Number Z-2125-2014
Recall Event ID 68744
Product Classification General surgery tray (kit) - Product Code LRO
Product DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Code Information Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
FDA Determined
Cause 2		 Packaging change control
Action The recall was initiated by letter delivered via UPS on 6/4/2014. The firm requested that the consignee contact Stericycle to arrange for return and replacement of the product. A second notice was sent on 7/22/2014 to those accounts who did not respond to the initial notice. Distributors were requested to notify their end-users or provide a list of end-users to DeRoyal for direct notification. Effectiveness checks will be sent via email for those customers who have provided an email contact and via UPS for those customers who have not responded.
Quantity in Commerce 230 units
Distribution Distributed in the states of MI, GA, OH, IL, MO, and IN.
Total Product Life Cycle TPLC 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.
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