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Class 2 Device Recall DeRoyal |
 |
| Date Initiated by Firm |
July 03, 2007 |
| Date Posted |
August 29, 2007 |
| Recall Status1 |
Terminated 3 on June 12, 2008 |
| Recall Number |
Z-1204-2007 |
| Recall Event ID |
39374 |
| Product Classification |
surgical procedure kits - Product Code KDD
|
| Product |
Assorted sterile surgical kits/ trays:
DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849;
DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only, DeRoyal, Powell, TN 37849;
DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Pack, REF 50-13134.09, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Ortho Ba |
| Code Information |
DeRoyal Neuro Tray, REF 89-4502.05, Lots: 12319975, exp 2008-01 and 12521971, exp 2008-01, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849 DeRoyal Diskectomy Pack, REF 89-4504.03, Lots: 12319983, exp 2009-02 and 12521989, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Tray, REF 89-3948.05, Lot 12319595, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cath Lab Tray, REF 89-4100.03, Lots: 12219616, exp 2012-07 and 12519205, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Knee Tray, REF 89-4191.06, Lot 12364881, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, Lot 12364899, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, Lot 12364944, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Thoracotomy Tray, REF 89-4199.06, Lot 12365082, exp 2011-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, Lot 12365162, exp 2009-06, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849 DeRoyal ACF Tray, REF 50-11919.13, Lot 12365381, exp 2009-01, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849 DeRoyal Ortho III, REF 89-2761.04, Lot 12365584, exp 2012-04, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849 DeRoyal LAP GYN, REF 89-2995.07, Lot 12365681, exp 2010-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Pack, REF 89-3068.11, Lot 12365728, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Head and Neck Tray, REF 89-3281.04, Lot 12365939, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Sinus Tray, REF 89-3952.03, Lot 12366270, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy, REF 89-4052.03, Lot 12366341, exp 2011-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-4138.02, Lot 12366448, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Plastics Tray, REF 89-4197.04, Lot 12366544, exp 2011-071, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Laparotomy Pack, REF 89-4312.04, Lot 12366632, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal OR Tray, REF 89-4422.02, Lot 12366755, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Breast Augmentation Pack, REF 89-4447.03, Lot 12366801, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal ORTHO Pack, REF 89-4482.03, Lot 12366923, exp 2008-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Joint Tray, REF 89-4613.06, Lot 12367205, exp 2012-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Hip Joint Tray, REF 89-4614.05, Lot 12367192, exp 2012-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Podiatry Tray, REF 89-4976.02, Lot 12367344, exp 2011-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Tray, REF 94-0148.03, Lot 12367408, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-4998.03, Lot 12367521, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, Lot 12368259, exp 2012-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Lap Banding Pack, REF 89-5693.01, Lots: 12368304, exp 2010-01 and 12580436, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Pack, REF 89-5703.01, Lot 12368380, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Pack, REF 89-5715.01, Lot 12368460, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C/V Pack Tray, REF 20-011700.12, Lot 12368654, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Heart Pack, REF 20-12059.16A, Lot 12368726, exp 2009-01, sterile, Rx only.DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-3146.06, Lot 12332598, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Pacemaker, REF 89-4024.06, Lot 12332871, exp 2008-07, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Lithotomy Tray, REF 89-4193.05, Lot 12332951, exp 2009-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Angiography Drape Pack, REF 89-4278.05, Lot 12332993, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Minor General Pack, REF 89-4289.05, Lot 12333005, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, Lot 12334155, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Knee Tray, REF 50-12456.07, Lot 12345743, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Tray, REF 89-4697.03, Lot 12428901, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Pack, REF 50-13134.08, Lot 12345786, exp 2011-09, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Vascular Tray, REF 89-3561.06, Lot 12346308, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, Lots: 12332598, exp 2012-01 and 12580532, exp. 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Pack, REF 50-13134.09, Lot 12428987, exp 2011-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Ortho Basic Tray, REF 89-2650.14, Lot 12429040, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Head/Neck Pack, REF 89-5736.01, Lots: 12430307, exp 2012-04 and 12475708, exp. 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Pack, REF 50-12783.06, Lot 12323683, exp 2011-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal AAA Tray, REF 89-3453.05 A, Lots: 12324310, exp 2009-12 and 12572647, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal AAA Tray, REF 89-3453.05 B, Lot 12572647, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Foot Pack, REF 89-5713.01, Lot 12429963, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cardiac Cath Tray, REF 50-13027.16, Lot 12274383, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Dr. D. C. Pack, REF 50-8858.24, Lots: 12242699, exp 2012-03 and 12384540, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal PEDS Accessory Tray, REF 50-13017.16, Lot 12458553, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Head and Neck Tray, REF 50-7738.18, Lot 12411413, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Spine Tray II Pgybk, REF 89-3792.04 A, Lot 12411552, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, Lot 12411552, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Tray, REF 94-0007.08, Lot 12411886, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray, REF 89-4196.10 A, Lot 12411958, exp 2009-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray, REF 89-4196.10 B, Lot 12411958, exp 2009-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray, REF 89-4196.10 S, Lot 12411958, exp 2009-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Tray, REF 89-4184.05, Lot 12411991, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cysto Tray, REF 89-3251.07, Lot 12412441, exp 2009-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Tray, REF 89-3619.04, Lot 12412539, exp 2009-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Tray, REF 89-3948.05, Lot 12412643, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Hand/Foot Tray, REF 89-4181.06, Lot 12412782, exp 2011-07, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Pack, REF 89-4251.03, Lot 12412926, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Knee Arthroscopy Pack, REF 89-4307.05, Lot 12412942, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 89-4342.02, Lot 12412951, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Arthroscopy, REF 89-4453.02, Lot 12412993, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, Lot 12413099, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal General Pack, REF 89-5231.03, Lot 12413355, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Knee Arthroscopy Pack, REF 89-5295.01, Lot 12413443, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Thoracotomy Tray, REF 50-8130.09, Lot 12414227, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal JIT C-Section Pack, REF 89-2572.06, Lot 12586395, exp 2008-09, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section w/Pouch Drape, REF 89-3435.02, Lot 12403616, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 50-11064.09, Lot 12403878, exp 2011-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray II, REF 89-3181.05, Lot 12403915, exp 2010-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, Lots: 12404070, exp 2009-03, 12521946, exp 2008-12, 12459425, exp 2009-04sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray, REF 50-4504.14, Lot 12383918, exp 2011-07, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 50-12788.08, Lot 12383951, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Carotid Tray, REF 50-7650.22, Lot 12384013, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal General/Plastic Tray Standard, REF 89-5031.01, Lot 12384030, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cataract Tray, REF 50-12183.07, Lot 12384072, exp 2010-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cath Lab Tray, REF 50-12050.11, Lot 12404070, exp 2009-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Ear Tray, REF 50-3028.18, Lot 12384435, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal All Service Basic, REF 89-2651.09, Lot 12384831, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal CV Drape Pack, REF 89-5137.01, Lot 12385024, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Tray, REF 89-5164.02, Lot 12385032, exp 2011-08, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Arthroscopy, REF 89-5258.05, Lots: 12385083, exp 2010-01 and 12454739, exp. 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C Section Tray Pgybk, REF 94-0101.08, Lot 12355044, exp 2008-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cysto Tray, REF 89-3251.07, Lot 12355247, exp 2009-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Liposuction Tray, REF 89-3763.02, Lot 12355271, exp 2012-04 sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, Lot 12355343, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Pack, REF 89-5725.01, Lot 12358149, exp 2010-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Tray I, REF 89-3182.05, Lot 12411958, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Endo Tray, REF 89-3462.06, Lots: 12358350, exp 2009-01 and 12459353, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arteriogram Tray, REF 50-12994.14, Lots: 12364354, exp 2011-11 and 12555935, exp. 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip, REF 50-13535.08, Lot 12364362, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Pack, REF 89-2746.03, Lot 12364573, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-3645.03, Lot 12364821, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Dr. K. Tray, REF 89-4004.05, Lot 12364872, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Pack, REF 89-2310.02, Lot 12538617, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Knee Tray, REF 89-3987.04, Lot 12519150, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, Lot 12519176, exp 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Endo Tray, REF 89-3456.04, Lots: 12459409, exp 2009-02 and 12521866, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Minor Tray, REF 89-3823.13, Lot 12587742, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Pack, REF 89-5154.01, Lot 12588323, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 89-5291.01, Lot 12588462, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Hand Pack, REF 89-5810.01, Lot 12589019, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 50-11036.07, Lot 12589060, exp 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal CABG Pack, REF 50-13509.10, Lot 12589107, exp 2008-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip Basin Set, REF 89-1319.05, Lots: 12589158, exp 2009-02 and 12459311, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Knee Basin Set, REF 89-1321.07, Lots: 12589166, exp 2009-02 and 12628508, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip, REF 89-2608.06, Lot 12490799, exp 2012-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Angiography Tray, REF 89-3558.07, Lot 12490975, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Abdohyst, Lapaexpl, REF 89-2497.12, Lot 12491601, exp 2008-09, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal General Surgery Tray, REF 89-4094.02, Lot 12490975, exp 2012-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, Lot 12491994, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal TAH Tray, REF 89-2672.09, Lot 12587523, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Hernia Tray, REF 89-3468.04, Lot 12459361, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Tray 3/Case, REF 50-2688.19, Lot 12586512, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Peripheral Vascular Tray, REF 89-3874.05, Lot 12586555, exp 2011-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Abdominal Tray, REF 89-4155.04, Lot 12466107, exp 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Pack, REF 89-5339.02 A, Lots: 12589326, exp 2009-01 and 12572727, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Pack, REF 89-5339.02 B, Lot 12572727, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAP Chole Tray, REF 50-12892, Lot 12586889, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Auxilary Towel Pack, REF 50-12925.11, Lot 12586918, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Fayette Arthroscopy Tray, REF 50-12975.06, Lots: 12586951, exp 2010-02 and 12429488, exp. 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Craniotomy Tray, REF 89-3563.11, Lots: 12473315, exp 2008-11 and 12604848, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal O.R. Basin Tray 4/CS, REF 50-3482.22, Lot 12473374, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Set, REF 89-3514.05, Lot 12473420, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Tray, REF 89-4849.02, Lot 12473462, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-3188.07, Lot 12474086, exp 2012-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Major Vascular Tray, REF 89-3561.07, Lot 12474211, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Pack, REF 89-4101.06, Lot 12474351, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Extremity Pack, REF 89-4309.05, Lot 12474529, exp 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Minor Joint Tray, REF 89-4615.05, Lot 12474756, exp 2011-08, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Shoulder Arthroscopy Pack, REF 89-4974.03, Lot 12474799, exp 2012-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Set, REF 94-0146.05, Lots: 12474861, exp 2012-05 and 12579945, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Pack, REF 50-12111.02, Lot 12475767, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Upper Extremity Value Set, REF 89-4426.04, Lot 12454667, exp 2008-07, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Laparotomy Pack, REF 50-12471.07, Lot 12429402, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Podiatry Tray, REF 50-835.06, Lot 12429568, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Cath Tray, REF 89-4173.05, Lot 12429200, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cardiac Cath Tray, REF 50-13119.19, Lot 12429234, exp 2008-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Limb Pack, REF 50-3836.23, Lot 12429285, exp 2012-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Tray, REF 89-5113.05, Lot 12656023, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Pack, REF 89-5798.01, Lot 12628268, exp 2012-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Pacemaker Tray, REF 89-3727.06, Lot 12640110, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Kellog Back Pack, REF 89-5817.01, Lot 12640523, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Pack, REF 89-5155.02, Lot 12624777, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Abdominalplasty Tray, REF 89-5677.01, Lot 12364573, exp 2009-10, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Pack, REF 89-5812.01, Lot 12624929, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal General Orthopedic Tray, REF 89-2851.06, Lots: 12578336, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip Pack, REF 89-3876.03, Lot 12578598, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal LAMI Pack, REF 89-4114.03, Lot 12578660, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Podiatry Tray, REF 50-13341.04, Lot 12578811, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Knee Tray, REF 89-3288.04, Lot 12578993, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic LAP Tray, REF 89-3297.06, Lot 12579005, exp 2012-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, Lots: 12579806, exp 2009-03 and 12537016, exp 2009-04, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal NW ASC Shoulder Arthro, REF 89-4569.07, Lot 12579814, exp 2008-12, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal TVT Pack, REF 89-5782.01, Lots: 12580727, exp 2010-01 and 12538203, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Double Basin Set, REF 89-0191.05, Lot 12580807, exp 2008-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Vascular AV Fistula Pack, REF 50-8118.08, Lot 12580874, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Pack, REF 50-12988.10, Lot 12556006, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Gyn Laparoscopy, REF 89-2646.10, Lot 12556196, exp 2011-11, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Heart Tray, REF 89-3916.05 A, Lot 12571927, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Heart Tray, REF 89-3916.05 B, Lot 12571927, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Arthroscopy Tray, REF 89-5714.01, Lot 12572401, exp 2010-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Lumbar Disk, REF 89-3390.06, Lot 12535310, exp 2009-03, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cath Lab Accessory Tray, REF 89-4023.07, Lot 12535547, exp 2009-02, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Extremity Pack, REF 89-2565.08, Lot 12535598, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Custom hand Tray, REF 89-4593.03, Lot 12537067, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Basic Major Tray, REF 94-0283.11, Lot 12537201, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Cardiac Cath Lab Tray, REF 89-5109.01, Lot 12537251, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Open Heart Drape Pack, REF 89-5202.01, Lot 12537358, exp 2012-05, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 A, Lot 12537500, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 B, Lot 12537500, exp 2009-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal Clevens Facelift Pack, REF 89-5728.01, Lot 12538094, exp 2010-01, sterile, Rx only, DeRoyal, Powell, TN 37849 DeRoyal C-Section Tray, REF 50-12505.08, Lot 12538596, exp 2008-12, 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 |
2023 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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