BEUDAMED
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    Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

    FDA Recall
    Terminated ·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010

    Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JQW·March 5, 2004

    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·October 17, 2017

    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·October 17, 2017

    Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·October 17, 2017

    ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·October 17, 2017

    Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LZH·June 27, 2008

    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·October 17, 2017

    ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code MPB·October 17, 2017

    Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care.

    FDA Recall
    Terminated ·Abbott Nutrition, Abbott Laboratories·Product code LZH·September 4, 2009

    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    FDA Recall
    Terminated ·Atossa Genetics, Inc.·Product code KNW·September 19, 2013

    Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".

    FDA Recall
    Terminated ·Product code RGB·November 19, 2010

    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011

    ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·June 7, 2011