FDA Medical Device Recalls (openFDA)

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, 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

Recall number: Z-1205-2007
Recalling firm: DeRoyal Lafollette
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
Status: Terminated
Initiated: 2007-07-03
Posted: 2007-08-29
Terminated: 2008-06-12
Reason: Packaging failure. Lack of sterility assurance
Root cause: 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: 112 cases
Distribution: Nationwide
Lot, serial or model codes: 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
510(k) numbers: not on file
PMA numbers: not on file
Product code: KDD
Firm FEI: 3005011024
Firm city: La Follette
Firm state: TN
Firm country: not on file

Where this comes from

Register: FDA Medical Device Recalls (openFDA)
Publisher: U.S. Food and Drug Administration (openFDA)
File: device-recall-0001-of-0001.json.zip
sha256: b87518bfe2e8
Size: 288210821 bytes
Published: 2026-09-28
Read: 2026-09-29T08:25:23.626Z
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Refresh due: 2026-10-06

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FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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