BEUDAMED
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    Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 6, 2016

    Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·March 2, 2016

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·October 24, 2012

    BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·February 11, 2015

    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 22, 2015

    *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 6, 2016

    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 22, 2017

    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·July 29, 2015

    *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 6, 2016

    Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Closure Systems, Research Triangle Park, NC 27709; REF 544250

    FDA Recall
    Terminated ·Teleflex Medical·Product code FZP·April 12, 2006

    Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Closure Systems, Research Triangle Park, NC 27709; REF 544230

    FDA Recall
    Terminated ·Teleflex Medical·Product code FZP·April 12, 2006

    Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Closure Systems, Research Triangle Park, NC 27709; REF 544240

    FDA Recall
    Terminated ·Teleflex Medical·Product code FZP·April 12, 2006

    Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, sterile, single use, disposable clip applier with medium size, non-absorbable polymer ligation clips; 15 clips per applier, 3 appliers per sales unit, 6 sales units per case; Mfg. by Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709; REF 543965

    FDA Recall
    Terminated ·Teleflex Medical·Product code FZP·April 12, 2006