The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
111
High
490
Moderate
214
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 13% are Severe.

Which agencies issued them

601–700 of 865

  • HighFDA (Devices)·Z-3401-2018·2018-10-10

    B. Braun Recalls EC20CS Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC20CS Epidural Catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3319-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling specific Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3384-2018·2018-10-10

    B. Braun Pediatric Catheter Connector Recall for Leakage and Disconnection

    B. Braun Medical is recalling 516 pediatric catheter connector sets because they may not stay closed, causing leakage or disconnection.

    Product
    CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0001-2019·2018-10-10

    Lamb Weston Recalls Hash Brown Patties Due to Plastic Fragments

    Lamb Weston is recalling specific hash brown patty brands because they may contain small fragments of hard, clear plastic.

    Product
    Formed Hash Brown Patties, packaged in cardboard trays covered with plastic film, frozen products. The following brands are subject to this recall. ***Brookshire's Golden Hash Brown Patties. Firm and address listed on label: "Brookshire Grocery Company PO Box 1411 Tyler,
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-3370-2018·2018-10-10

    B. Braun Medical Recalls CE17TKPS Continuous Epidural Anesthesia Trays

    B. Braun Medical is recalling CE17TKPS Continuous Epidural Anesthesia Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Rolls Recalled for Sterility Breach Risk

    COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise sterility.

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3318-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Ultra Catheter Connectors

    B. Braun Medical is recalling Contiplex Tuohy Ultra catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3387-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,030 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3388-2018·2018-10-10

    B. Braun Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling 200 spinal/epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3332-2018·2018-10-10

    B. Braun Medical Recalls CE17TKFCPS Epidural Full Tray Connectors

    B. Braun Medical is recalling CE17TKFCPS Epidural Full Tray connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3337-2018·2018-10-10

    B. Braun Medical Recalls CE18HKST Catheter Connectors Due to Leakage

    B. Braun Medical is recalling CE18HKST epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3331-2018·2018-10-10

    B. Braun Medical Recalls Epidural Basic Trays Due to Connector Leakage

    B. Braun Medical is recalling CE17TBFC Epidural Basic Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2019·2018-10-10

    Oridion Capnostream20 N Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling five Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 N W/PRINTER CYVITAL, CS08798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3314-2018·2018-10-10

    B. Braun Contiplex Cont Nerve Block Connectors Recalled for Leakage

    B. Braun Medical is recalling 108 Contiplex Cont Nerve Block connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3396-2018·2018-10-10

    B. Braun EC19C Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling EC19C catheter connectors because they may not stay closed, leading to leakage or disconnection during use.

    Product
    EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3365-2018·2018-10-10

    B. Braun Medical Recalls CE18HB Epidural Catheter Connectors

    B. Braun Medical is recalling CE18HB epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3361-2018·2018-10-10

    B. Braun Medical Recalls CE18TBLS Epidural Tray Connectors

    B. Braun Medical is recalling CE18TBLS epidural tray connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3393-2018·2018-10-10

    B. Braun Medical Recalls Spinal and Epidural Catheter Connectors

    B. Braun Medical is recalling ES1827KDS Spinal/Epidural Full Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3345-2018·2018-10-10

    B. Braun Medical Recalls CNB200TKU Non-Stim Catheter Full Kits

    B. Braun Medical is recalling 880 units of CNB200TKU Non-Stim Catheter Full Kits because the connectors may not stay closed, leading to leakage or disconnection.

    Product
    CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3352-2018·2018-10-10

    B. Braun Recalls CE17T Continuous Epidural Sets Due to Leakage

    B. Braun Medical is recalling 504 CE17T Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3386-2018·2018-10-10

    B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage

    B. Braun Medical is recalling 1,020 epidural trays because catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3356-2018·2018-10-10

    B. Braun Medical Recalls CE18TKCD Epidural Catheter Connectors

    B. Braun Medical is recalling CE18TKCD epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2019·2018-10-10

    Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur without intended respiratory gating.

    Product
    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3343-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 93,140 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2019·2018-10-10

    Purus Labs MYOWHEY Whey Protein Recalled for Undeclared Milk and Soy

    Purus Labs is recalling MYOWHEY Premium Whey Protein due to undeclared milk and soy allergens. The product was distributed in nine US states and two foreign countries.

    Product
    Purus Labs MYOWHEY Premium Whey Protein, Chocolate Cookie Crunch, 75 True Servings, Net Wt. 5 lb / 2.26 kg. UPC 55734-00285. Manufactured for and distributed by Purus Labs, 2601 Resource Drive, Plano, TX 75704
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3325-2018·2018-10-10

    B. Braun Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling specific catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3392-2018·2018-10-10

    B. Braun Medical Recalls Espocan Spinal/Epid Trays Due to Leakage

    B. Braun Medical is recalling 1,490 Espocan Spinal/Epid Trays because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3390-2018·2018-10-10

    B. Braun Medical Recalls ESPOCAN Combined 27GA Catheter Connectors

    B. Braun Medical is recalling ESPOCAN Combined 27GA catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3338-2018·2018-10-10

    B. Braun Perifix Epidural Tray Recall for Connector Leakage

    B. Braun Medical is recalling Perifix Continuous Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3328-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Echo OT Catheter Connectors

    B. Braun Medical is recalling 190 units of Contiplex Echo OT catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3348-2018·2018-10-10

    B. Braun Catheter Connector Recall Due to Leakage and Disconnection

    B. Braun Medical is recalling CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components

    Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.

    Product
    Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19705·2018-10-10

    Spiraledge Recalls Backless Yoga Chairs Due to Fall Hazard

    Spiraledge is recalling Everyday Yoga backless chairs because they can break at the rear support rod, posing a fall hazard. One minor injury has been reported.

    Product
    Everyday Yoga Backless Yoga Chairs and Everyday Yoga Tall Backless Yoga Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Monitors Recalled for Settings Reset

    Oridion Medical is recalling 264 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0017-2019·2018-10-10

    Burger-Shaped Chocolate Cookies Recalled for Partially Covered Allergen Information

    Wismettac Asian Foods is recalling Everyburger chocolate cookies because a sticker partially covers the ingredient list and allergen information.

    Product
    EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32 oz. (66 g) There are 2 packing sizes; 10 items per case and 80 items per case UPC 8 055880 00701 0 Manufactured by Bourbon 1-3-1 Ekimae Kashiwazaki Nigata 945-8611 Japan Product of Japan
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-3362-2018·2018-10-10

    B. Braun Medical Recalls ACCU-BLOC PERIFIX Kits Due to Leakage

    B. Braun Medical is recalling CE18TK ACCU-BLOC PERIFIX Kits because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3346-2018·2018-10-10

    B. Braun Medical Recalls Non-Stim Catheter Full Kits Due to Leakage

    B. Braun Medical is recalling 2,740 CNB400TKU Non-Stim Catheter Full Kits because the connectors may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3380-2018·2018-10-10

    B. Braun Recalls 2800 Clamp Style Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 2,800 clamp style catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3353-2018·2018-10-10

    B. Braun Medical Recalls CE17TO Epidural Catheter Connectors

    B. Braun Medical is recalling CE17TO epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3324-2018·2018-10-10

    B. Braun Contiplex Cont Nerve Block Catheter Connectors Recalled for Leakage

    B. Braun Medical is recalling 4,510 units of CNB400TK Contiplex Cont Nerve Block catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3327-2018·2018-10-10

    B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection

    B. Braun Medical is recalling 430 units of CONT STIM BASIC KIT W/4 IN INSUL TUOHY catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3317-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling 5,460 units of CNB200T Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3391-2018·2018-10-10

    B. Braun Recalls Spinal and Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling ES1827K Spinal/Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3379-2018·2018-10-10

    B. Braun Perifix One Epidural Full Tray Recall for Connector Issues

    B. Braun Medical is recalling Perifix One Epidural Full Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3349-2018·2018-10-10

    B. Braun Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling 1,350 CNB400TU3KUE catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3334-2018·2018-10-10

    B. Braun Medical Recalls CE17TKFSA Full Tray Catheter Connectors

    B. Braun Medical is recalling CE17TKFSA full trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3373-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,760 CE18TOD epidural tray connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3385-2018·2018-10-10

    B. Braun Accu-Bloc Perifix Kit Recalled for Catheter Leakage

    B. Braun Medical is recalling 1,380 Accu-Bloc Perifix Kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3339-2018·2018-10-10

    B. Braun Perifix FX Catheter Connectors Recalled for Leakage and Disconnection

    B. Braun Medical is recalling Perifix FX catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3313-2018·2018-10-10

    B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection

    B. Braun Medical is recalling 600 CONTI TUOHY ULTRA 360 catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19704·2018-10-10

    Canyon Recalls Mountain Bikes Due to Chainstay Crash Hazard

    Canyon is recalling about 820 model year 2018 Spectral mountain bikes because the aluminum chainstays can crack, posing a crash hazard.

    Product
    Mountain bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3280-2018·2018-10-10

    Ortho-Clinical VITROS Sodium Slides Recalled for Potential Positively Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides due to a potential for positively biased results. The recall covers multiple generations and expiry dates distributed globally.

    Product
    VITROS Sodium Slides, Catalog # 837 9034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0010-2019·2018-10-10

    Baker's Service of South Florida Recalls Cheese Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 706 cases of Cheese Pastry because the product labeling failed to declare wheat as an ingredient.

    Product
    Cheese Pastry. The product is packed in a cardboard box. The firm marks the Cheese Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, CHEESE PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING, INGREDI
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0009-2019·2018-10-10

    Baker's Service Recalls Meat Flavored Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 179 cases of Meat Flavored Pastry because the finished product labeling failed to declare wheat.

    Product
    Meat Flavored Pastry. The product is packed in a cardboard box. The firm marks the Meat Flavored Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, MEAT FLAVORED PASTRY, HANDLING INSTRUCTIONS, PREPARAT
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3341-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,040 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3367-2018·2018-10-10

    B. Braun Medical Recalls Epidural Anesthesia Kits Due to Leakage

    B. Braun Medical is recalling CE17TKCD epidural anesthesia kits because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3316-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Ultra Catheter Connectors

    B. Braun Medical is recalling 168 Contiplex Tuohy Ultra 2-in-1 connector sets because the connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2019·2018-10-10

    Oridion CapnoStream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 192 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2019·2018-10-10

    Oridion CapnoStream 20P Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 1,038 CapnoStream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3358-2018·2018-10-10

    B. Braun Medical Recalls CE18TKDP Catheter Connectors Due to Leakage

    B. Braun Medical is recalling CE18TKDP catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2019·2018-10-10

    ICU Medical Bifuse Transfer Set Recalled Due to Missing Blood Filter

    ICU Medical is recalling 2,361 Bifuse Transfer Sets because a design change removed the blood filter, creating a risk of use as a blood transfusion set.

    Product
    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system t
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-3360-2018·2018-10-10

    B. Braun Medical Recalls 18GA Tuohy Catheter Connectors for Leakage

    B. Braun Medical is recalling 18GA Tuohy catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3376-2018·2018-10-10

    B. Braun Recalls Epidural Catheter Connectors Due to Leakage and Disconnection

    B. Braun Medical is recalling 4,150 epidural catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2019·2018-10-10

    Vision RT AlignRT Plus Integrated Gate Controller PCB Recall

    Vision RT Ltd is recalling 690 AlignRT Plus systems due to an RTInterface error that can occur during I/O communication between the Integrated Gate Controller PCB and the Framegrabber PCB.

    Product
    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3355-2018·2018-10-10

    B. Braun Medical Recalls CE18H Continuous Epidural Sets

    B. Braun Medical is recalling CE18H Continuous Epidural Sets because the catheter connectors may not stay closed, potentially causing leakage or disconnection.

    Product
    CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3400-2018·2018-10-10

    B. Braun Medical Recalls EC20CST 20G Soft Tip Catheter Connectors

    B. Braun Medical is recalling EC20CST 20G Soft Tip Catheter Connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3282-2018·2018-10-10

    Rayner C-flex Intraocular Lens Recall Due to Refractive Errors

    Rayner Intraocular Lenses Limited is recalling 49 C-flex 570C +19.0D intraocular lenses distributed in Missouri due to reports of post-operative refractive errors.

    Product
    C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3335-2018·2018-10-10

    B. Braun Medical Recalls CE18TKST Epidural Catheter Connectors

    B. Braun Medical is recalling CE18TKST epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2019·2018-10-10

    Kerlix Gauze Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.

    Product
    Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3344-2018·2018-10-10

    B. Braun Recalls CE17TKFS Epidural Trays Due to Connector Leakage

    B. Braun Medical is recalling CE17TKFS Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2019·2018-10-10

    Heartware HVAD System Controllers Recalled for Potential Water Ingress

    Heartware, Inc. is recalling HVAD System Controllers because they may develop hairline cracks at the power ports, potentially failing to meet standards for protection against water or fluid ingress.

    Product
    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3315-2018·2018-10-10

    B. Braun Contiplex Cont Nerve Block Connectors Recalled for Leakage

    B. Braun Medical is recalling Contiplex Cont Nerve Block connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3399-2018·2018-10-10

    B. Braun Medical Recalls EC20O Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC20O catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0059-2019·2018-10-10

    Ortho VITROS FSH Reagent Pack Recalled for Potential Biased Results

    Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.

    Product
    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0006-2019·2018-10-10

    Sichuan Friendly Pharmaceutical Recalls Thyroid Powder Due to CGMP Deviations

    Sichuan Friendly Pharmaceutical Co., Ltd. is recalling Thyroid Powder 25kg/drum because the product has inconsistent levels of active ingredients.

    Product
    Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0052-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 11 refurbished Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M REFURBISHED, CS78654
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2019·2018-10-10

    Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 696 Capnostream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2019·2018-10-10

    Oridion Capnostream20 M Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling three Capnostream20 M bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M W/PRINTER CYVITAL, CS08796
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0055-2019·2018-10-10

    Oridion CapnoStream 20P Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 16 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 46 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) N REFURBISHED, Part Number CS78651
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Monitors Recalled for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2019·2018-10-10

    Exactech Equinoxe Reverse Drill Bit Kit Recalled for Incorrect Components

    Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.

    Product
    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0045-2019·2018-10-10

    Oridion Capnostream20 M Adult ICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling five Capnostream20 M Adult ICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M ADULT ICU (CPM), CS08654RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 769 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M, Part Number CS08653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 43 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US)M REFURBISHED, Part Number CS78653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER, CS08660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0053-2019·2018-10-10

    Oridion Capnostream20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling six refurbished Capnostream20 patient monitors because alarm and time settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2019·2018-10-10

    Oridion Capnostream20 M NICU Monitors Recalled for Settings Reset

    Oridion Medical is recalling 262 Capnostream20 M NICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 M NICU (CPM), CS08654RN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2019·2018-10-10

    Ortho VITROS Folate Reagent Pack Recall for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.

    Product
    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2019·2018-10-10

    Oridion Capnostream20 Bedside Monitors Recalled for Settings Reset Defect

    Oridion Medical is recalling 400 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
    Category
    Medical Device
    Distribution
    Distributed nationwide

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