The Recall Desk

Archive

February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical
88
Severe
191
High
354
Moderate
163
Low
19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

501–600 of 815

  • SevereFDA (Devices)·Z-1040-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1013-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Royalsilk Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0980-2020·2020-02-12

    Pacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance

    Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.

    Product
    Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Food)·F-0664-2020·2020-02-12

    Lipari Foods Recalls Fresh Grab Chicken Sandwiches for Listeria Risk

    Lipari Foods is recalling Fresh Grab Chicken Sandwiches due to potential contamination with Listeria monocytogenes. The affected products were distributed to food service and retail stores in 15 states.

    Product
    Fresh Grab Chicken Sandwich, 3.5 oz., UPC: 612510007020
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0636-2020·2020-02-12

    Golden State Foods Recalls Coleslaw Dressing Due to Metal Fragments

    Golden State Foods is recalling Colonel's Coleslaw Dressing used by Pizza Hut due to potential metal fragments in a starch ingredient.

    Product
    Colonel's Coleslaw Dressing; GIN: 0030920 FG: 02612/102186 9 - 4.75 lb. (2.15kg) Pouches Net Weight: 42.75 lbs. Supplier ID: 0005320-01 GSF Product # 02620 Customer Product #: 0030920 Packed exclusively for use by Pizza Hut and its franchisees and licensees. Pizza Hut
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1002-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Fabric Reinforced Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V078000·2020-02-12

    2019 Mercedes-Benz and Freightliner Sprinter EGR Pipe Fire Risk Recall

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because loose EGR pipe screws may allow hot exhaust gases to leak, increasing the risk of a fire.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0915-2020·2020-02-12

    ResMed Stellar Ventilators Recalled for Potential Alarm Failure

    ResMed is recalling 69 Stellar ventilators because a software and component failure may prevent audible alarms from operating properly.

    Product
    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
    Category
    Medical Device
    Distribution
    9 states
  • SevereNHTSA·20V079000·2020-02-12

    2019 Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Exhaust Leak

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vehicles because an exhaust gas leak could increase the risk of a fire.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 1500, SPRINTER 3500, SPRINTER 4500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2020·2020-02-12

    Cardinal Health recalls surgical gowns due to unknown contamination levels

    Cardinal Health is recalling AAMI 3 Royalsilk surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V076000·2020-02-12

    Audi TT Recall: Fuel Tank Heat Shield Bracket Fire Risk

    Volkswagen is recalling 2016-2019 Audi TT vehicles because a fuel tank heat shield bracket may damage the tank in a crash, causing a fuel leak and fire risk.

    Product
    AUDI — AUDI TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0644-2020·2020-02-12

    Razzoo's Gumbo Base Recalled for Undeclared Codfish Powder

    National Food & Beverage, Inc. is recalling Razzoo's Gumbo Base in Texas due to undeclared codfish powder, a potential allergen hazard.

    Product
    Razzoo's Gumbo Base 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1072-2020·2020-02-12

    Centurion Vaginal Speculums Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.

    Product
    Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Biopsy and Prep Packs Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific sterile medical packs and trays because incomplete seals may compromise sterility.

    Product
    Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2020·2020-02-12

    Cook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk

    Cook Inc. is recalling 3,929 PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Nonreinforced Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2020·2020-02-12

    Centurion Medical Suture Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling various suture and laceration trays because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2020·2020-02-12

    Biomerieux VIDAS 3 Immunoanalyzer Recalled for False Results Due to Software Error

    Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.

    Product
    BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0634-2020·2020-02-12

    Golden State Foods Recalls Garlic Parmesan Sauce Due to Metal Fragments

    Golden State Foods is recalling Garlic Parmesan Sauce produced for Domino's Pizza due to potential metal fragments in a starch ingredient.

    Product
    Garlic Parmesan Sauce; DP# 4478 FG# 02620 8/16 fl. oz (4.73 ml) pouches; NET WT. 8.05 lbs (3.65 kg) Produced for Domino's Pizza Ann Arbor MI 48105
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1098-2020·2020-02-12

    Stryker Telescopic Smoke Evac Pencil Recalled for Electrical Arcing Risk

    Stryker is recalling Telescopic Smoke Evac Pencils because hairline fractures could cause electrical current to arc, potentially burning patients or users.

    Product
    Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0642-2020·2020-02-12

    Tres Coronas Bakery Recalls Flour Tortillas for Undeclared Wheat

    Tres Coronas Bakery is recalling Red Apple and Tres Coronas brand flour tortillas sold in Oregon due to undeclared wheat.

    Product
    Flour Tortillas are packaged in clear plastic bags, 12 count per bag and sold under brands Red Apple. Product is also sold under Tres Coronas brand and it has 10 counts per bag. The Red Apple brand label is read in parts: "***Flour Tortillas *** INGREDIENTS: FLOUR, WATER, SAL
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1077-2020·2020-02-12

    Centurion Medical Valve Change Kit Recalled for Incomplete Sterile Seals

    Centurion Medical Products Corporation is recalling Valve Change Kits due to incomplete sterile package seals that may compromise sterility.

    Product
    Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0590-2020·2020-02-12

    Munk Pack Keto Dark Chocolate Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling specific lots of Keto Nut and Seed Dark Chocolate Sea Salt Bars because they may contain undeclared milk.

    Product
    Munk Pack Keto Nut and Seed Dark Chocolate Sea Salt Bar, 35 g, individual unit
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1055-2020·2020-02-12

    Centurion Medical Products Recalls Pelvic Exam Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling various pelvic exam trays because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2020·2020-02-12

    Centurion Skin Prep Tray Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling Skin Prep Trays due to incomplete seals on the sterile package, which may compromise sterility.

    Product
    Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2020·2020-02-12

    Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling various LVAD kits because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2020·2020-02-12

    Cook Inc. Recalls Universa Firm Ureteral Stents Due to Loading Error

    Cook Inc. is recalling Universa Firm Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2020·2020-02-12

    B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 5,616 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0646-2020·2020-02-12

    Razzoo's Creole Sauce Recalled for Undeclared Codfish Powder

    National Food & Beverage is recalling Razzoo's Creole Sauce in Texas due to undeclared codfish powder, a potential allergen hazard.

    Product
    Razzoo's Creole Sauce 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0641-2020·2020-02-12

    Granuts BBQ Mix Recalled for Undeclared Wheat and Soy Allergens

    Compania Nacional de Chocolates DCR S.A. is recalling Granuts BBQ Mix in Puerto Rico due to undeclared wheat and soy allergens.

    Product
    Granuts BBQ Mix, Net Wt/Cont. Neto 16.93 oz (480g), Contains 12 units x 1.41 oz (40g) ea. and Net Wt/Cont. Neto 6.35 oz (180g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0632-2020·2020-02-12

    Meijer Joint Health Supplement Recalled for Missing Shellfish Allergen Labeling

    Merical, LLC is recalling Meijer Joint Health Movement Advanced Dietary Supplement because the label fails to declare crustacean shellfish as an allergen.

    Product
    Meijer Joint Health Movement Advanced Dietary Supplement with Glucosamine + Chondroitin. 1500 mg; Supports Joint Mobility and Comfort; Unit Size - 80 count - 2 tablets per day. Item Numbers: MEIJER7383 UPC Code: 713733562966 Distributed by Meijer Distribution Inc. Grand
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0645-2020·2020-02-12

    Razzoo's Etouffee Sauce Recalled for Undeclared Codfish Powder

    National Food & Beverage is recalling Razzoo's Etouffee Sauce in Texas due to undeclared codfish powder, a potential allergen.

    Product
    Razzoo's Etouffee Sauce 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0975-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling Sof-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20T003000·2020-02-12

    Tornel A/T-09 Tires Recalled for Sidewall Separation Risk

    Tornel is recalling specific A/T-09 tires due to improper manufacturing that may cause sidewall separation, increasing the risk of tire failure and a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0592-2020·2020-02-12

    Munk Pack Coconut Cocoa Chip Keto Granola Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling Coconut Cocoa Chip Keto Granola Bars because they may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Munk Pack Coconut Cocoa Chip Keto Granola Bar, 4 pack, 128 g
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1070-2020·2020-02-12

    Centurion Biopsy Tray Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 60 Biopsy Trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0719-2020·2020-02-12

    Beepa's Goulash Starter Recalled for Undeclared Milk Allergen

    Beepas LLC is recalling Beepa's Original Goulash Starter because it contains undeclared milk. The product was distributed in Illinois and Wisconsin.

    Product
    Beepa's Original Goulash Starter, 32 oz. (2 PTS) 946.35ml. UPC 60000-90711
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1000-2020·2020-02-12

    Zimmer Biomet Recalls Coonrad/Morrey Total Elbow Humeral Assembly Due to Pin Error

    Zimmer Biomet is recalling three units of the Coonrad/Morrey Total Elbow Humeral Assembly because the lot contained two outer pins instead of one outer and one inner pin.

    Product
    Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0934-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1032-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2020·2020-02-12

    Cook Percutaneous Pigtail Nephrostomy Set Recalled for Wire Guide Loading Error

    Cook Inc. is recalling Percutaneous Pigtail Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2020·2020-02-12

    Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift

    Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings remain within the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2020·2020-02-12

    Cocoon Convective Warming System Recalled for Thermal Damage Risk

    Care Essentials is recalling 689 Cocoon Convective Warming Systems due to a risk of thermal damage near the power cord connector and Power Entry Module.

    Product
    Cocoon Convective Warming System, Product Code: CWS4000 (110V).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2020·2020-02-12

    Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Seals

    Centurion Medical Products Corporation is recalling various LVAD maintenance kits because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2020·2020-02-12

    Centurion Pelvic Exam Kits Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling specific lots of Pelvic Exam Kits because incomplete seals may compromise sterility.

    Product
    Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0654-2020·2020-02-12

    Lipari Foods Recalls Turkey and Cheese Sandwiches for Listeria Risk

    Lipari Foods is recalling Premo and Fresh Grab Turkey & Cheese Wedge Sandwiches due to potential contamination with Listeria monocytogenes.

    Product
    Premo and Fresh Grab Turkey & Cheese Wedge Sandwich, 5 oz., UPC: 612510002018
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1078-2020·2020-02-12

    Centurion Glass Medicine Cup Recall Due to Incomplete Sterile Seals

    Centurion Medical Products is recalling 600 sterile glass medicine cups because incomplete seals may compromise sterility.

    Product
    Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2020·2020-02-12

    Centurion Umbilical Vessel Catheter Recall Due to Incomplete Seals

    Centurion Medical Products is recalling Umbilical Vessel Catheter Insertion devices due to incomplete sterile package seals that may compromise sterility.

    Product
    Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0828-2020·2020-02-12

    Ascend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations

    Ascend Laboratories is recalling 192 bottles of Olmesartan Medoxomil 20 mg tablets because they were released in error with an alternate API source before approval.

    Product
    OLMESARTAN MEDOXOMIL — OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2020·2020-02-12

    Centurion Recalls Umbilical Trays Due to Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling specific umbilical trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2020·2020-02-12

    Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

    Product
    Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2020·2020-02-12

    Centurion Skin Prep Kits Recalled for Incomplete Seals

    Centurion Medical Products is recalling 108 units of Skin Prep Kits due to incomplete seals that may compromise sterility.

    Product
    Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2020·2020-02-12

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Defective Capacitors

    Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.

    Product
    da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2020·2020-02-12

    Cook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets

    Cook Inc. is recalling Bander Ureteral Diversion Open-End Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2020·2020-02-12

    Centurion Medical Recalls Skin Prep Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific lots of sterile skin prep trays because incomplete seals may compromise sterility.

    Product
    Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2020·2020-02-12

    Roche Recalls Accu-Chek Aviva Plus Blood Glucose Test Strips

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.

    Product
    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2020·2020-02-12

    Centurion Tracheostomy Care Kits Recalled Due to Incomplete Package Seals

    Centurion Medical Products is recalling specific tracheostomy care kits and trays because incomplete seals may compromise sterility.

    Product
    Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2020·2020-02-12

    B. Braun Y-Type Blood Set Recall Due to Leakage Risk

    B. Braun Medical is recalling 2,736 Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2020·2020-02-12

    Centurion OR2020 Basin Set Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling 188 units of the OR2020 Basin Set because incomplete seals may compromise sterility.

    Product
    Centurion- OR2020 BASIN SET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2020·2020-02-12

    B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 9,000 Y-Type Blood Sets because of a potential for leakage at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2020·2020-02-12

    Cook Inc. Recalls Percutaneous Entry Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling 13,388 Percutaneous Entry Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2020·2020-02-12

    Cook Inc. Recalls Kwart Retro-Inject Ureteral Stent Sets

    Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2020·2020-02-12

    Centurion Uterine Sound Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling sterile uterine sounds because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2020·2020-02-12

    Centurion Tracheostomy Care Kits Recalled Due to Incomplete Package Seals

    Centurion Medical Products is recalling specific tracheostomy care kits because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.

    Product
    Urethral Dilator Set, Global Product No. G14185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2020·2020-02-12

    Cook Inc. Recalls Roadrunner Hydrophilic PC Wire Guides Due to Loading Error

    Cook Inc. is recalling Roadrunner Hydrophilic PC Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2020·2020-02-12

    Centurion Medical Products Recalls Surgical Trays Due to Incomplete Seals

    Centurion Medical Products is recalling specific surgical trays because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2020·2020-02-12

    Cook Inc. Recalls Bentson PTFE Wire Guides Due to Loading Error

    Cook Inc. is recalling Bentson PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2020·2020-02-12

    Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination

    Cardinal Health is recalling RoyalSilk XLARGE gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK XLARGE, Gown. Item Code 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2020·2020-02-12

    Cook Inc. Recalls C-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2020·2020-02-12

    Centurion Medical Products Recalls Dressing Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific dressing trays and medical packs because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2020·2020-02-12

    Ethicon Recalls VICRYL Sutures Due to Braid Fraying

    Ethicon is recalling specific VICRYL sutures because braid fraying may reduce tensile strength. The recall covers 23,688 units distributed in the US and Puerto Rico.

    Product
    Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2020·2020-02-12

    Cook Inc. Recalls Percutaneous Malecot Nephrostomy Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling 13,388 Percutaneous Malecot Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2020·2020-02-12

    Centurion Ultrasound Guided PIV Kit Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling 350 ultrasound guided PIV kits due to incomplete sterile package seals that may compromise sterility.

    Product
    Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2020·2020-02-12

    Centurion Circumcision Trays Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 1,986 circumcision trays because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects

    Centurion Medical Products is recalling specific sterile dressing change kits because incomplete seals may compromise sterility. The recall covers kits distributed nationwide and in Ghana.

    Product
    Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2020·2020-02-12

    Centurion Medical Recalls Sterile Surgical Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific sterile surgical trays because incomplete seals may compromise sterility. The affected products were distributed nationwide and in Ghana.

    Product
    Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2020·2020-02-12

    Cook Inc. Recalls Universa Soft Ureteral Stents Due to Wire Guide Loading Error

    Cook Inc. is recalling Universa Soft Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2020·2020-02-12

    Centurion Dental Kits Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling 1,720 dental kits because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Kits Due to Incomplete Seals

    Centurion Medical Products is recalling specific sterile medical kits because incomplete seals may compromise sterility.

    Product
    Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2020·2020-02-12

    Centurion Medical Laceration Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling various laceration and medical trays due to incomplete seals on sterile packages that may compromise sterility.

    Product
    Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2020·2020-02-12

    Centurion Infant Feeding Kit Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products Corporation is recalling Infant Feeding Kits due to incomplete seals on the sterile package, which may compromise sterility.

    Product
    Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2020·2020-02-12

    Centurion PT225 Pain Management Tray Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling 420 PT225 Pain Management Trays due to incomplete seals that may compromise sterility.

    Product
    Centurion- PT225 PAIN MANAGEMENT TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2020·2020-02-12

    Centurion Neonatal PICC Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 957 Neonatal PICC Trays due to incomplete seals that may compromise sterility. The units were distributed nationwide and to Ghana.

    Product
    Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2020·2020-02-12

    B. Braun Recalls Safeline Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 3,300 units of Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

    Product
    Safeline Y-Type Blood Set, Catalog Number NF5140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2020·2020-02-12

    B. Braun Outlook Safety Infusion System Y-type Blood Set Recall for Leakage

    B. Braun Medical is recalling 1,824 Outlook Safety Infusion System Y-type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

    Product
    Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2020·2020-02-12

    Centurion Medical Recalls Umbilical Catheter Trays Due to Incomplete Seals

    Centurion Medical Products Corporation is recalling specific umbilical catheter trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Surgery Kits Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific lots of sterile surgery kits because incomplete seals may compromise sterility.

    Product
    Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1114 BIOPSY TRAY DYNDH1131 WDC ULTRASOUND KIT DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1227A HOL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
    Category
    Medical Device
    Distribution
    Distributed nationwide

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