The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
129
High
473
Moderate
213
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 15% are Severe.

501–600 of 865

  • SevereNHTSA·18V710000·2018-10-11

    Toyota Recalls 2019 C-HR Vehicles Due to Rear Axle Bolt Issues

    Toyota is recalling 2019 C-HR vehicles because rear axle hub bearing bolts may be insufficiently tightened. This defect could damage brake components or cause a rear wheel to detach, increasing crash risk.

    Product
    TOYOTA — TOYOTA C-HR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V713000·2018-10-11

    BMW Recalls M3 and M4 Models for Driveshaft Connection Failure

    BMW is recalling 2016-2017 M3 and M4 vehicles because the driveshaft connection may fail, causing a loss of propulsion and increasing crash risk.

    Product
    BMW — BMW M4, M3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V712000·2018-10-11

    Erwin Hymer Recalls 2018-2019 Motorhomes Due to Generator Overcharging

    Erwin Hymer is recalling 172 motorhomes because the generator may overcharge auxiliary batteries, potentially causing acid spills if non-sealed batteries are used.

    Product
    ROADTREK — ROADTREK, HYMER, CARADO SIMPLICITY SRT, AKTIV 2.0, AKTIV, BANFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·090-2018·2018-10-11

    Valley Fine Foods Recalls Meat and Poultry Products Due to Spoilage

    Valley Fine Foods is recalling approximately 35,516 pounds of heat-treated meat and poultry products that may be adulterated with spoilage organisms.

    Product
    Valley Fine Foods Recalls Meat and Poultry Products due to Possible Adulteration
    Category
    Food
    Distribution
    6 states
  • LowNHTSA·18V711000·2018-10-11

    Toyota Recalls 2018-2019 Tundra for Incorrect Load Capacity Label

    Toyota is recalling 2018-2019 Tundra vehicles because the load carrying capacity label incorrectly overstates weight by 10 pounds, failing federal safety standards.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·088-2018·2018-10-10

    Malone's Fine Sausage Recalls Pork Head Cheese Due to Listeria

    Malone's Fine Sausage is recalling pork head cheese products potentially contaminated with Listeria monocytogenes. The products were sold in Illinois, Michigan, and Wisconsin.

    Product
    Malone's Fine Sausage, Inc. — Malone's Fine Sausage, Inc. Recalls Pork Head Cheese Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-3321-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage

    B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3381-2018·2018-10-10

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

    B. Braun Medical is recalling 6,850 clamp-style catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0009-2019·2018-10-10

    Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling

    Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.

    Product
    robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2019·2018-10-10

    Endologix AFX2 Bifurcated Endograft System Recall for Type III Endoleaks

    Endologix is notifying physicians about the AFX2 Bifurcated Endograft System due to observed Type III endoleaks. This is a follow-up to a December 2016 notification.

    Product
    ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40…
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-3364-2018·2018-10-10

    B. Braun Medical Recalls CE18TB Epidural Trays Due to Leakage

    B. Braun Medical is recalling CE18TB epidural trays because the catheter connectors may not stay closed, causing leakage or disconnection.

    Product
    CE18TB CONT EPIDURAL TRAY, Material Number 332222 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
  • SevereFDA (Devices)·Z-3375-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 1,980 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 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
  • SevereFDA (Food)·F-1991-2018·2018-10-10

    Neighbors LLC Recalls Gluten-Free Cookie Dough for Undeclared Almonds

    Neighbors LLC is recalling 7,264 units of Crazy About Cookies Gluten Free Chocolate Chip Cookie Dough because the packaging fails to declare almonds as an ingredient.

    Product
    Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUGH**Net Wt. 2 lbs. (907.18g)**Nutrition facts***Ingredients: Whole grain sorghum flour, cane sugar, semi sweet chocolates**Contains eggs, milk and soy.***Manufactured in the same equipment that manufactures peanut…
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-0008-2019·2018-10-10

    Endologix AFX Endograft Recall for Type III Endoleak Surveillance

    Endologix is notifying physicians of updated surveillance recommendations for AFX endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75…
    Category
    Medical Device
    Distribution
    52 states
  • SevereNHTSA·18E095000·2018-10-10

    Alpha Technology Ignition Switch Recall Due to Engine Stall Risk

    Alpha Technology is recalling mechanical key ignition switches that may shift out of the RUN position, causing the engine to turn off and increasing crash risk.

    Product
    ELECTRICAL SYSTEM:IGNITION:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0064-2019·2018-10-10

    Leica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard

    Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.

    Product
    Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0020-2019·2018-10-10

    Meijer Taco Seasoning Mix Recalled for Undeclared Milk

    McCormick is recalling Meijer Taco Seasoning Mix because it contains undeclared milk. The product was distributed to six Midwestern states.

    Product
    Meijer Taco Seasoning Mix, Net wt. 4.5 oz.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (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
  • SevereNHTSA·18V697000·2018-10-10

    Daimler Recalls 2018-2019 Freightliner Trucks for Engine Ground Stud Defect

    Daimler Trucks North America is recalling 2018-2019 Freightliner MT45G and MT55G vehicles because an improperly tightened engine ground stud may cause overheating and increase the risk of fire.

    Product
    FCCC — FCCC MT55G, MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2019·2018-10-10

    Endologix AFX Endovascular AAA System Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for the AFX Endovascular AAA System due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40…
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-0005-2019·2018-10-10

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0009-2019·2018-10-10

    Endologix AFX Limb Extension Endograft Recall for Type III Endoleaks

    Endologix is notifying physicians of surveillance recommendations for AFX Limb Extension Endografts due to observed Type III endoleaks.

    Product
    ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX…
    Category
    Medical Device
    Distribution
    52 states
  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3330-2018·2018-10-10

    B. Braun Medical Recalls 17GA Safety Tuohy Needle Trays

    B. Braun Medical is recalling 17GA Safety Tuohy Needle Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2019·2018-10-10

    Ellex iScience Recalls Canaloplasty Microcatheter Kits Due to Sterility Failure

    Ellex iScience is recalling 90 units of the iTRACK 250A Canaloplasty Microcatheter Kit because a sterility failure was found in one unit of the lot.

    Product
    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3402-2018·2018-10-10

    B. Braun Medical Recalls EC20C Catheter Connectors Due to Leakage

    B. Braun Medical is recalling EC20C catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC20C 20G X 100CM CATH CLOSED, Material Number 333540 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
  • HighCPSC·19007·2018-10-10

    Briggs & Stratton Recalls Generator Fuel Caps Due to Fire Hazard

    Briggs & Stratton is recalling specific fuel tank replacement caps for portable generators because they lack ventilation holes, creating a fire hazard.

    Product
    Fuel tank replacement caps made by Kelch/Bemis
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3322-2018·2018-10-10

    B. Braun Medical Recalls Contiplex Insulated Tuohy Needle Connectors

    B. Braun Medical is recalling 144 units of CNB200S Contiplex Insulated Tuohy Needle connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3357-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling CE17TKCDLS epidural trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 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-0008-2019·2018-10-10

    Baker's Service Recalls Guava & Cheese Pastry for Undeclared Allergens

    Baker's Service of South Florida, Inc. is recalling 975 cases of Guava & Cheese Pastry because the packaging failed to declare wheat and specific color additives.

    Product
    Guava & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Guava & Cheese Pastry option printed on the box. Labeling for the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, GUAVA & CHEESE PASTRY, HANDLING INSTRUCTIONS…
    Category
    Food
    Distribution
    0 states
  • 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 (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…
    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-3329-2018·2018-10-10

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

    B. Braun Medical is recalling 590 CONTI ECHO CT catheter connector sets because they may not stay closed, leading to leakage or disconnection.

    Product
    CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 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…
    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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0064-2019·2018-10-10

    Bounty Foods Recalls Deep Pit Seasoning for Undeclared Wheat and Milk

    Bounty Foods, Inc. is recalling 60 jars of Deep Pit Seasoning due to undeclared wheat and milk. The product was distributed in Montana.

    Product
    Deep Pit Seasoning, net wt. 6 oz., packaged in a clear, wide mouth jar, black and white label with black lid. The product label is read in parts: "***Deep-pit Seasoning *** Ingredients: (Hydrolyzed vegetable & soy protein, lactose, salt, partially hydrogenated cottonseed &…
    Category
    Food
    Distribution
    1 state
  • 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-3340-2018·2018-10-10

    B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

    B. Braun Medical is recalling 2,420 epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Roll Recalled for Sterility Breach Risk

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

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 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-3351-2018·2018-10-10

    B. Braun Medical Recalls CE18TIN Epidural Set Connectors

    B. Braun Medical is recalling 372 CE18TIN epidural set connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE18TIN CONT EPIDURAL SET LF, Material Number 332201 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-3369-2018·2018-10-10

    B. Braun Medical Recalls CE18HKPS Continuous Epidural Trays

    B. Braun Medical is recalling CE18HKPS Continuous Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 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-3336-2018·2018-10-10

    B. Braun Medical Recalls CE17TKST Epidural Catheter Connectors

    B. Braun Medical is recalling CE17TKST epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 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-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-0038-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall

    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 - ROHS, Part Number CS08652-02
    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-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 (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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3363-2018·2018-10-10

    B. Braun Medical Recalls CE17TK Epidural Catheter Connectors

    B. Braun Medical is recalling 2,790 CE17TK epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    CE17TK CONT EPIDURALTUOHY, Material Number 332221 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-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…
    Category
    Medical Device
    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 (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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2019·2018-10-10

    Coviden EEA Circular Stapler Recalled for Potential Tissue Gap Defect

    Coviden is recalling 1,902 EEA Circular Staplers with Tri-Staple Technology due to a potential defect that may cause incomplete staple formation or device retention in tissue.

    Product
    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3342-2018·2018-10-10

    B. Braun Medical Recalls 17 GA Epidural Catheter Connectors

    B. Braun Medical is recalling specific epidural catheter connectors that may not stay closed, leading to potential leakage or disconnection.

    Product
    CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 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 (Food)·F-0011-2019·2018-10-10

    Baker's Service Recalls Apple Pastry for Undeclared Wheat Allergen

    Baker's Service of South Florida, Inc. is recalling Apple Pastry because the labeling failed to declare wheat, a major food allergen.

    Product
    Apple Pastry. The product is packed in a cardboard box. The firm marks the Apple Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, APPLE PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING…
    Category
    Food
    Distribution
    0 states
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3333-2018·2018-10-10

    B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage

    B. Braun Medical is recalling CE17TKFC Epidural Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

    Product
    CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3326-2018·2018-10-10

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

    B. Braun Medical is recalling 120 catheter connector kits because they may not stay closed, leading to leakage or disconnection.

    Product
    CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0007-2019·2018-10-10

    Baker's Service Recalls Guava Pastry for Undeclared Wheat and Color Additives

    Baker's Service of South Florida is recalling 975 cases of Guava Pastry because the labeling failed to declare wheat and specific color additives.

    Product
    Guava Pastry. The product is packed in a cardboard box. The firm marks the Guava Pastry option printed on the box. Labeling for the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, GUAVA PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING…
    Category
    Food
    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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2019·2018-10-10

    Kerlix Bandage Roll Recalled for Potential Sterility Breach

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

    Product
    Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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-3398-2018·2018-10-10

    B. Braun Medical Recalls EC19OF Springwound 19G Epidural Catheter Connectors

    B. Braun Medical is recalling EC19OF Springwound 19G epidural catheter connectors because they may not stay closed, leading to leakage or disconnection.

    Product
    EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 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-0013-2019·2018-10-10

    Kerlix AMD Antimicrobial Bandage Roll Recalled for Sterility Breach Risk

    Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0002-2019·2018-10-10

    Murry's Hash Brown Potato Patties Recalled for Plastic Fragments

    Lamb Weston Inc. is recalling Murry's Hash Brown Potato Patties because they may contain small fragments of hard, clear plastic.

    Product
    Murry's Hash Brown Potato Patties, packaged in cardboard trays covered with plastic film, frozen products. -Tray UPC 0 73744 04001 4, retail packaged in 40.5 OZ (2.53 LB) (1.14 kg). -Case item M06, case UPC 1 00 73744 04001 1, case net wt. 30.375 LBS. (13.8 kg) ***Packed…
    Category
    Food
    Distribution
    8 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…
    Category
    Food
    Distribution
    0 states
  • 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…
    Category
    Food
    Distribution
    8 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2019·2018-10-10

    Hemotherm 400CE Recalled for Control Panel Switch Errors

    Cincinnati Sub-Zero is recalling 270 Hemotherm 400CE devices due to potential control panel switch errors that may prevent setting changes or cause unintended changes.

    Product
    Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2019·2018-10-10

    Leica HistoCore SPECTRA CV Coverslipper Recalled for Electrical Shock Risk

    Leica Microsystems is recalling one HistoCore SPECTRA CV Coverslipper unit in Missouri due to a misplaced hose that creates an electrical shock hazard.

    Product
    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
    Category
    Medical Device
    Distribution
    1 state
  • 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…
    Category
    Medical Device
    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 (Devices)·Z-3368-2018·2018-10-10

    B. Braun Accu-Bloc Perifix Kit Recall for Catheter Connector Defects

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

    Product
    CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3405-2018·2018-10-10

    B. Braun Recalls Nonsterile Perifix Catheter Connectors Due to Leakage Risk

    B. Braun Medical is recalling 60,000 nonsterile Perifix catheter connectors because they may not stay closed, causing leakage or disconnection.

    Product
    BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0013-2019·2018-10-10

    Baker's Service Recalls Coconut Pastry for Undeclared Wheat

    Baker's Service of South Florida, Inc. is recalling 344 cases of Coconut Pastry because the finished product labeling failed to declare wheat.

    Product
    Coconut Pastry. The product is packed in a cardboard box. The firm marks the Coconut Pastry option printed on the box. Labeling on the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY,COCONUT PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING…
    Category
    Food
    Distribution
    0 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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