DeRoyal Lafollette 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, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
DeRoyal Lafollette
Lot Codes / Batch Numbers
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
Products Sold
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
DeRoyal Lafollette is recalling Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section Tracecart, REF 53-17 due to Packaging failure. Lack of sterility assurance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging failure. Lack of sterility assurance
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026