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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal

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  Class 2 Device Recall DeRoyal see related information
Date Initiated by Firm July 03, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on June 12, 2008
Recall Number Z-1205-2007
Recall Event ID 39374
Product Classification procedure trays - Product Code KDD
Product Assorted non- sterile Tracecarts (with sterile component(s));
DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1897.02, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1862.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracepak, REF 90-2774.10, non-sterile, Rx only, DeRoyal, Powell, TN 37849;
DeRoyal Total Knee Tracecart, REF 53-1838.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1837.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1781.04, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849;
DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849
Code Information DeRoyal C-Section Tracecart, REF 53-1746.02, Lot 12781158, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracepak, REF 90-2838.11, Lot 12830124, exp 2010-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracecart, REF 53-1865.03, Lot 12585413, exp 2008-08, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, Lot 12388751, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1763.02, Lot 12680189, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1897.02, Lot 12729915, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1862.03, Lot 12924403, exp 2010-05, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracepak, REF 90-2774.10, Lot 12493236, exp 2011-09, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Total Knee Tracecart, REF 53-1838.02, Lot 12585296, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, Lot 12570676, exp 2008-1105, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1725.13, Lot 12617657, exp 2008-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1837.03, Lot 11829924, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1781.04, Lot 12866047, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, Lot 12585405, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1815.06, Lot 12671151, exp 2008-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal AAA Tracecart, REF 53-1765.08, Lot 12862695 exp 2009-04, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1767.08, Lot 12671101, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849 
Recalling Firm/
Manufacturer		 DeRoyal Lafollette
1501 East Central Ave
La Follette TN 37766
For Additional Information Contact Mr. Steve Ward
865-362-1201
Manufacturer Reason
for Recall		 Packaging failure. Lack of sterility assurance
FDA Determined
Cause 2		 Other
Action Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product.
Quantity in Commerce 112 cases
Distribution Nationwide
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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