Class 2 Device Recall DeRoyal Surgical Kits and trays

• Date Initiated by Firm: June 14, 2011
• Date Posted: February 06, 2012
• Recall Status: Terminated on June 27, 2013
• Recall Number: Z-0963-2012
• Recall Event ID: 60852
• Product Classification: Tray, surgical - Product Code LRP
• Product: Sterile surgical kits: ; DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; ; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; ; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; ; DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; ; DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; ; DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02 Lot Numbers: 25744022, 26010670, 26194641; ; DeRoyal DISKECTOMY TRAY, REF 89-6196.03 Lot Number: 26097373; ; DeRoyal MAJOR DRAPE PACK, REF 89-7255.01 Lot Number: 26011736; ; DeRoyal EXTREMITY PACK PGYBK, REF 89-5275.05 Lot Number: 26063270; ; DeRoyal SCOPE SHOULDER TRAY, REF 89-5653.03 Lot Number: 26227422; ; DeRoyal KNEE SCOPE PACK, REF 89-5654.03 Lot Number: 26020510; ; DeRoyal BILATERAL DRAPE, REF 89-5379.02 Lot Number: 26042735, 26282421; ; DeRoyal LAPAROSCOPIC CHOLE PACK, REF 89-5259.05 Lot Number: 25817201; ; DeRoyal MAJOR HIP PACK, REF 89-4718.04 Lot Number: 25840313; ; DeRoyal SPINE PACK, REF 89-4150.06 Lot Number: 25933077; ; DeRoyal ARTHROSCOPY TRAY, REF 89-5317.02 Lot Number: 26078463; ; DeRoyal LARGE VASCULAR TRAY, Lot Number: 26078447; ; DeRoyal SMALL VASCULAR TRAY, REF 89-3694.13 Lot Number: 261449399; ; DeRoyal ASC VASCULAR PACK PGYBK, REF 89-6284.05 Lot Number: 25698986; ; DeRoyal ASC BREAST PACK, REF 89-6285.06, Lot Number: 26078578; ; DeRoyal ASC FOOT/ANKLE PACK, REF 89-6014.07 Lot Numbers: 26096856, 26147916; ; DeRoyal ACUTE BURN EXCISION TRAY, REF 89-3330.05 Lot Number: 26078367; ; DeRoyal RECONSTRUCTION TRAY, REF 89-3331.04 Lot Numbers: 25817383, 26019720; ; DeRoyal FOOT PACK, REF 89-6467.05 Lot Number: 25880438; ; DeRoyal TRAUMA PACK, REF 89-6776.04 Lot Number: 26010688; ; DeRoyal KNEE ARTHROSCOPY PACK, REF 89-5257.08 Lot Numbers: 26125434, 26149102; ; DeRoyal CHILDRENs ORTHOPEDIC TRAY, REF 89-3479.08 Lot Numbers: 25873676, 25905092 ; DeRoyal KNEE SCOPE, REF 89-2910.09 Lot Number: 25695611; ; DeRoyal SPINE PACK PGYBK, REF 89-6720.01 Lot Number: 26022048; ; DeRoyal OPEN SHOULDER PROCEDURE PACK, REF 89-6629.01 Lot Number: 25839187; ; DeRoyal ORTHO TOTAL BASIC TRAY, REF 89-2650.15 Lot Numbers: 25893423, 26010207, 26077111; ; DeRoyal ORTHO TOTAL HIP/KNEE TRAY, REF 89-2644.17 A & B Lot Number: 25894012; ; DeRoyal MINOR/PLASTIC PACK, REF 89-6994.02 Lot Number: 25853544; ; DeRoyal OPEN HEART PACK, REF 89-6996.02 Lot Number: 25853608; ; DeRoyal GEN SURG UNIV PACK, REF 89-6991.02 Lot Number: 25696032; ; DeRoyal PERI VASCULAR PACK, REF 89-6998.03 Lot Number: 25853587; ; DeRoyal VASCULAR PACK, REF 50-4157.29 Lot Number: 25732507; ; DeRoyal OPEN HEART B, REF 50-13010.19 Lot Number: 26009978; ; DeRoyal GENERAL ORTHO PACK, REF 89-6883.02 Lot Number: 25695911; ; DeRoyal HIP COUNTABLES TRAY, REF 89-5382.03 Lot Number: 26020464; ; DeRoyal BASIC ORTHO TRAY, REF 89-3389.11 Lot Number: 26010291; ; DeRoyal TOTAL KNEE PACK, REF 89-7114.02 Lot Number: 26012780; ; DeRoyal ACF TRAY, REF 89-7660.01 Lot Number: 26022656; ; DeRoyal HAND PACK, REF 89-7549.02 Lot Numbers: 26042330, 26147713; ; DeRoyal ORTHO PACK, REF 89-7546.02 Lot Numbers: 26025242, 26025717; ; DeRoyal THORACOTOMY PACK, REF 89-7536.02 Lot Number: 26022161; ; DeRoyal LAPAROSCOPIC GYN PACK, REF 89-7500.02 Lot Number: 26096063; ; DeRoyal ELG/AAA PACK, REF 89-7495.02 Lot Number: 26256371; ; DeRoyal PEDI OPEN HEART PACK, REF 89-7486.02 Lot Number: 26100624; ; DeRoyal TOTAL KNEE PACK, REF 89-7484.01 Lot Number: 25875196; ; DeRoyal TOTAL KNEE PACK, REF 89-7466.01 Lot Number: 26013301; ; DeRoyal CUSTOM TOTAL HIP PACK, REF 89-7465.03 Lot Number: 26096039, 26166244; ; DeRoyal PERIPHERAL VASCULAR PACK, REF 89-7451.02 Lot Number: 26166252; ; DeRoyal NEURO PACK, REF 89-7396.01 Lot Number: 26061573; ; DeRoyal LABOR & DELIVER PACK, REF 89-7448.03 Lot Number: 26166236; ; DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-7446.02 Lot Number: 26096549; ; DeRoyal GENERAL MINOR PACK, REF 89-7365.01 Lot Numbers: 25838838, 26095765; ; DeRoyal CUSTOM GENERAL MAJOR PACK, REF 89-7357.01 Lot Nu
• Code Information: REF 89-7284.02: Lot Number: 26166359 REF 89-7237.01: Lot Number: 26013627 REF 89-7229.01: Lot number: 26013635 REF 89-5256.06: Lot Number: 26185242 REF 89-5277.02: Lot Number: 25793211 REF 89-6773.02: Lot Numbers: 25744022, 26010670, 26194641 REF 89-6196.03: Lot Number: 26097373 REF 89-7255.01: Lot Number: 26011736 REF 89-5275.05: Lot Number: 26063270 REF 89-5653.03: Lot Number: 26227422 REF 89-5654.03: Lot Number: 26020510 REF 89-5379.02: Lot Number: 26042735, 26282421 REF 89-5259.05: Lot Number: 25817201 REF 89-4718.04: Lot Number: 25840313 REF 89-4150.06: Lot Number: 25933077 REF 89-5317.02: Lot Number: 26078463 REF 89-3693.13: Lot Number: 26078447 REF 89-3694.13: Lot Number: 261449399 REF 89-6284.05: Lot Number: 25698986 REF 89-6285.06: Lot Number: 26078578 REF 89-6014.07: Lot Numbers: 26096856, 26147916 REF 89-3330.05: Lot Number: 26078367 REF 89-3331.04: Lot Numbers: 25817383, 26019720 REF 89-6467.05: Lot Number: 25880438 REF 89-6776.04: Lot Number: 26010688 REF 89-5257.08: Lot Numbers: 26125434, 26149102 REF 89-3479.08: Lot Numbers: 25873676, 25905092 REF 89-2910.09: Lot Number: 25695611 REF 89-6720.01: Lot Number: 26022048 REF 89-6629.01: Lot Number: 25839187 REF 89-2650.15: Lot Numbers: 25893423, 26010207, 26077111 REF 89-2644.17 A & B: Lot Number: 25894012 REF 89-6994.02: Lot Number: 25853544 REF 89-6996.02: Lot Number: 25853608 REF 89-6991.02: Lot Number: 25696032 REF 89-6998.03: Lot Number: 25853587 REF 50-4157.29: Lot Number: 25732507 REF 50-13010.19: Lot Number: 26009978 REF 89-6883.02: Lot Number: 25695911 REF 89-5382.03: Lot Number: 26020464 REF 89-3389.11: Lot Number: 26010291 REF 89-7114.02: Lot Number: 26012780 REF 89-7660.01: Lot Number: 26022656 REF 89-7549.02: Lot Numbers: 26042330, 26147713 REF 89-7546.02: Lot Numbers: 26025242, 26025717 REF 89-7536.02: Lot Number: 26022161 REF 89-7500.02: Lot Number: 26096063 REF 89-7495.02: Lot Number: 26256371 REF 89-7486.02: Lot Number: 26100624 REF 89-7484.01: Lot Number: 25875196 REF 89-7466.01: Lot Number: 26013301 REF 89-7465.03: Lot Number: 26096039, 26166244 REF 89-7451.02: Lot Number: 26166252 REF 89-7396.01: Lot Number: 26061573 REF 89-7448.03: Lot Number: 26166236 REF 89-7446.02: Lot Number: 26096549 REF 89-7365.01: Lot Numbers: 25838838, 26095765 REF 89-7357.01: Lot Number: 25874821 REF 89-7353.01: Lot Number: 26013862 REF 89-7327.02 & .03: Lot Numbers: 26012878, 26061611 REF 89-7326.02: Lot Number: 26013791 REF 89-6466.03: Lot Number: 26064133 REF 89-7198.02: Lot Numbers: 26011461, 26114751 REF 89-7192.02: Lot Number: 26013061 REF 89-7179.03: Lot Number: 26012229 REF 89-7177.03: Lot Number: 26061362 REF 89-7163.01: Lot Numbers: 26013299, 26114794 REF 89-7102.02: Lot Numbers: 25941536, 26011453 REF 89-7103.02: Lot Number: 26062031 REF 89-7105.03: Lot Numbers: 25941704, 26061371 REF 89-7117.01: Lot Numbers: 25744508, 25957301, 26095722 REF 89-7070.02: Lot Number: 26042137 REF 89-7029.02: Lot Number: 26011331 REF 89-7020.02: Lot Number: 26012704 REF 89-7076.03: Lot Numbers: 26012755, 26095749 REF 89-7069.01: Lot Number: 25814941 REF 50-13042.12: Lot Number: 25839929 REF 50-13200.13: Lot Number: 25878602 REF 89-6868.02: Lot Number: 25838731 REF 89-7001.03: Lot Numbers: 25854070, 25765333 REF 89-7011.02: Lot Number: 25853341 REF 89-7146.01: Lot Number: 26096186 REF 89-7185.01: Lot Number: 26011832 REF 94-0093.11: Lot Number: 26185197 REF 94-0097.11: Lot Number: 26136601 REF 89-7665.02: Lot Numbers: 26016318, 26097592 REF 89-7661.01: Lot Number: 26077698 REF 89-5113.09: Lot Number: 26018452 REF 89-7116.01: Lot Number: 26012712 REF 89-3695.13: Lot Numbers: 26042701, 26099432 REF 89-5396.03 A & B: Lot Number: 25792577 REF 89-6697.03: Lot Numbers: 25696067, 26146690 REF 89-7113.03: Lot Number: 25874231 REF 89-4164.06: Lot Number: 26098608 REF 89-4612.06: Lot Number: 25647601 REF 89-5720.02: Lot Number: 25746298 REF 89-6428.01: Lot Numbers: 25699111, 26021547 REF 89-6352.03: Lot Number: 26100026 REF 89-6348.03: Lot Number: 26021336 REF 89-6798.01: Lot Number: 25838686 REF 89-6799.01: Lot Number: 26094906
• 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: Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes.
• FDA Determined Cause: Nonconforming Material/Component
• Action: DeRoyal Industries Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL OF KIMBERLY-CLARK THREE-QUARTER DRAPE 79147" letter dated June 14, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify and quarantine all affected product. Further instructions by the firm asks customers to complete and return a Recall Response Spreadsheet via fax to 865-362-3744. Customers should contact their Deroyal Sales Representative for questions or assistance regarding this recall.
• Quantity in Commerce: 3881 kits
• Distribution: Nationwide Distribution.
• 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.