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    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Enforcement
    Class II ·Terminated·89 NORTH·September 2, 2020

    Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·BARD PERIPHERAL VASCULAR, INC·January 25, 2017

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·March 11, 2021

    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GCJ·July 1, 2016

    Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Brand names: 1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; 2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.; 3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.; 4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. 10-8917, Net Wt. 2 oz, Cat. No. 10-8946, Net Wt. 5 g, Triad Plus Cat. No. 11-8344, 3 g., Cat. No. 11-8472, 5 grams, Cat. No. 10-8919, Net Wt. 4 oz, Cat. No. 10-8500, Net Wt. 4 oz; 5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.; 6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.; 7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.

    FDA Recall
    Terminated ·H & P Industries, Inc. dba Triad Group·Product code KMJ·December 23, 2010

    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.

    FDA Recall
    Terminated ·St. Jude Medical·Product code JOQ·March 23, 2009

    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.

    FDA Recall
    Terminated ·Product code FGE·June 10, 2005

    ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN

    FDA Recall
    Terminated ·Product code FGE·July 1, 2008

    Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

    FDA Recall
    Terminated ·Product code DXE·May 18, 2007

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 4, 2012

    ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,

    FDA Recall
    Terminated ·Product code FGE·July 1, 2008

    Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code DTA·August 31, 2005

    Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product #42620. The firm name on the label is ITW Dymon, Olathe, KS. The product is also distributed under the following private labels: (1) Area Two-In-One Disinfectant Spray Country, Reorder #ADI-531, Sold By Area Distributors, Inc., Quincy, IL; (2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc., Corporate Headquarters Des Plaines, IL; (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company, Charlotte, NC; (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny''s Sanitary Supplies, Inc., New Orleans, LA; (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc., Blue Springs, MO; (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products, Cleveland, OH; (8) Sterling Quality Nature''s Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp., Sheboygan, WI; (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC, Deerfield, IL; (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc., Depew, NY; (12) Dazzle ''D'' Disinfectant Spray Country Garden, Sold By Henry Kraft Inc., Nevada, MO; (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc., Huntington Station, NY; (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc., St. Louis, MO; (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp., Portland, OR; (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc., Neptune Beach, FL; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries, Phoenix, AZ; (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific, Sparks, NV; (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc., St. Charles, IL. One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated, Winona, MN.

    FDA Recall
    Terminated ·ITW Dymon·Product code LRJ·February 15, 2005

    Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DTB·September 1, 2009

    Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005

    Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Guidant Corporation·Product code DXY·September 22, 2005