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    DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code KDD·October 1, 2008

    "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010

    "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010

    ArrowClarke" PleuraSeal Thoracentesis Kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code KDD·October 24, 2017

    DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code KDD·October 1, 2008

    Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KDD·May 19, 2009

    Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KDD·April 10, 2008

    "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin marker with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Chloraprep Swabsticks. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010

    Maximal Barrier Drape; Product Code: ASK-01000-UPMS

    FDA Recall
    Terminated ·Arrow International Inc·Product code KDD·April 11, 2018

    BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Component is found in: TMJ SYSTEM ARTHROSIMPLICITY KIT REF 922070, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com Kit contains individually packaged sterile products. Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·January 9, 2009

    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

    FDA Recall
    Terminated ·DeRoyal Lafollette·Product code KDD·July 3, 2007

    AMS 4674 Custom Pack. For use in a general clinical procedure.

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code KDD·November 2, 2015

    Pneumothorax Kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code KDD·October 24, 2017

    Large Volume Abdominal Paracentesis Kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code KDD·October 24, 2017

    Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code KDD·April 8, 2021

    "***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" KIT WAS DISCONTINUED. Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin market with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Choloraprep Swabsticks; Shelf drape. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·October 8, 2010

    Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KDD·April 10, 2008

    BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Component is found in: TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT, REF 24-3050, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com Kit contains individually packaged sterile products. Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code KDD·January 9, 2009

    Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal MINOR INTERVENTIO

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code KDD·February 7, 2012

    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

    FDA Recall
    Terminated ·DeRoyal Lafollette·Product code KDD·July 3, 2007