Events

Recall of Device Recall DeRoyal Surgical Kits and trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Industries Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60852
  • Event Risk Class
    Class 2
  • Event Number
    Z-0963-2012
  • Event Initiated Date
    2011-06-14
  • Event Date Posted
    2012-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106645
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tray, surgical - Product Code LRP
  • Reason
    Custom surgical kits contain recalled kimberly clark surgical drapes which were found to contain metal shavings in the folds of the drapes.
  • 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.

Device

Device Recall DeRoyal Surgical Kits and trays
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA