The Recall Desk

Archive

June 2014 recalls

399 recalls were announced in June 2014.

What the numbers show

Critical
28
Severe
90
High
152
Moderate
113
Low
16

Of the 399 recalls this month scored against our rubric, 7% are Critical, 23% are Severe.

Which agencies issued them

201–300 of 399

  • ModerateFDA (Devices)·Z-1769-2014·2014-06-18

    Stryker 5.0mm Acorn Bur Recalled for Missing Notches

    Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.

    Product
    Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1758-2014·2014-06-18

    Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no notches.

    Product
    Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2014·2014-06-18

    Stryker Precision Neuro Drill Recall Due to Missing Notches

    Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1736-2014·2014-06-18

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.

    Product
    VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1777-2014·2014-06-18

    Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories

    Stryker is recalling 497 sterile neuro drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite attachments.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2014·2014-06-18

    Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1751-2014·2014-06-18

    Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.

    Product
    Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1780-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1779-2014·2014-06-18

    Stryker 5.0mm Barrel Bur Recall for Missing Notches

    Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2014·2014-06-18

    Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1759-2014·2014-06-18

    Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 84 sterile 5.5mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.

    Product
    Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2014·2014-06-18

    Stryker Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 609 sterile 3.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2014·2014-06-18

    Stryker 6.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 256 units of 6.0mm Round Fluted Bur due to missing or partial notches that may affect compatibility with Elite Attachments.

    Product
    Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1768-2014·2014-06-18

    Stryker 5.0mm Barrel Bur Recall Due to Missing Notches

    Stryker is recalling 15 units of 5.0mm Barrel Bur Sterile because some units may have missing or partial notches.

    Product
    Stryker 5.0mm Barrel Bur Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1766-2014·2014-06-18

    Stryker 5.0mm Egg Bur Recall Due to Missing Notches

    Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.

    Product
    Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1773-2014·2014-06-18

    Stryker Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 246 sterile 1.5mm Wire Pass Drills because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1752-2014·2014-06-18

    Stryker 4.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 281 units of 4.0mm Round Fluted Burs because some may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1737-2014·2014-06-18

    Beckman Coulter Recalls Ultrasonic Transducer Kits Due to Incorrect Screws

    Beckman Coulter is recalling 82 Ultrasonic Transducer Kits because they may have been assembled with incorrect mounting screws.

    Product
    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1750-2014·2014-06-18

    Stryker Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 72 sterile 1.0mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2014·2014-06-18

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software issue that may cause biased results when using Multiple Window codes.

    Product
    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.

    Product
    enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in th
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1776-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 188 sterile neuro drill accessories because some units have missing or partial notches, which may affect their use with Elite attachments.

    Product
    Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1781-2014·2014-06-18

    Synthes Mandible Plate Cutter Recalled for Potential Corrosion

    Synthes, Inc. is recalling 14 units of the Matrix Mandible Short Cut Plate Cutter due to potential discoloration and corroded material on the tool's face.

    Product
    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1739-2014·2014-06-18

    Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Manganese Contamination

    Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate bottles because the container caps may contain foreign material with elevated manganese levels.

    Product
    NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1771-2014·2014-06-18

    Stryker Lindemann Drill Short Recalled for Missing Notches

    Stryker is recalling 12 Lindemann Drill Short units because some cutting accessories may have missing or partial notches.

    Product
    Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications inclu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1787-2014·2014-06-18

    Beekley Spots Light Image O-Spots Recalled for Mislabeled Dispenser

    Beekley Corporation is recalling 81 boxes of Light Image O-Spots for mammography because the dispensers were mislabeled as S-Spots.

    Product
    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1731-2014·2014-06-18

    Summit Medical Recalls Mixed Lot of Armstrong Grommet Ventilation Tubes

    Summit Medical, Inc. is recalling one lot of Armstrong Grommet ventilation tubes due to mixed flange types. The agency states this poses no health hazard to users or patients.

    Product
    Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V333000·2014-06-17

    Lion 360 School Bus Seat Belt Buckle Recall

    Lion Bus is recalling 2014 360 school buses because seat belt buckles may fail to release, hindering emergency egress.

    Product
    LION — LION 360
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V331000·2014-06-17

    American Coach Recalls 2015 Motor Homes Due to Seat Belt Defect

    Allied Recreation Group is recalling 2015 American Coach motor homes because incorrect seat belt installation may cause fraying and reduced strength.

    Product
    AMERICAN COACH — AMERICAN COACH AMERICAN EAGLE, AMERICAN TRADITION, AMERICAN REVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V330000·2014-06-17

    American Coach Motor Homes Recalled for Defective Seat Belt Attachments

    Allied Recreation Group is recalling 2013-2014 American Coach motor homes because incorrect seat belt attachments may cause fraying and reduced strength.

    Product
    AMERICAN COACH — AMERICAN COACH AMERICAN EAGLE, AMERICAN REVOLUTION, AMERICAN TRADITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V329000·2014-06-16

    MCI Motor Coaches Recalled for Interior Lighting Fire Risk

    Motor Coach Industries is recalling certain 2009-2011 MCI D4000, D4500, and 2010 D4505 motor coaches because excessive power draw from LED interior lights may cause heat buildup and fire.

    Product
    MCI — MCI D4000, D4500, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·035-2014·2014-06-13

    Vanee Foods Recalls Turkey Base Due to Undeclared Milk Allergen

    Vanee Foods is recalling approximately 3,156 pounds of turkey base misbranded as chicken base because it contains undeclared milk, a known allergen.

    Product
    Vanee Foods Company — Illinois Firm Recalls Turkey Base Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·14V323000·2014-06-13

    Honda Recalls Acura ILX Vehicles for Headlight Fire Risk

    Honda is recalling certain 2013-2014 Acura ILX vehicles because excessive heat around the headlight bulb may cause smoke, melting, or fire, increasing crash risk.

    Product
    ACURA — ACURA ILX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V328000·2014-06-13

    Ford F-Series Trucks Recalled for PTO Switch Fire Risk

    Iowa Mold Tooling is recalling 2009-2014 Ford F-350, F-450, and F-550 SD trucks because a leaking PTO pressure switch may cause a fire.

    Product
    FORD — FORD F-450 SD, F-350 SD, F-550 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E030000·2014-06-13

    Meritor Recalls MFS12143ANN Axles Due to Weak Beam Spots

    Meritor is recalling specific MFS12143ANN non-drive steer axles because manufacturing errors may have created weak spots in the beam, increasing the risk of sudden axle failure and a crash.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V326000·2014-06-13

    Manning Recalls Modified Ford Super Duty Trucks Due to Fire Risk

    Manning Equipment is recalling 2012-2013 modified Ford Super Duty trucks because oil leaks from the PTO pressure switch onto the exhaust thermal blanket, increasing fire risk.

    Product
    FORD — FORD F-350 SD, F-450 SD, F-550 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V322000·2014-06-12

    Winnebago Recalls 2014-2015 Motorhomes for Electrical Corrosion Risk

    Winnebago is recalling 2014-2015 Travato, Trend, and Itasca Viva motorhomes because water intrusion may cause electrical corrosion that disables safety features.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, ITASCA VIVA, TREND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V319000·2014-06-12

    Harley-Davidson Recalls 2014 Touring Motorcycles Due to Brake Line Pinch Risk

    Harley-Davidson is recalling 66,421 model year 2014 Touring and CVO Touring motorcycles because a front brake line may be pinched, potentially causing front wheel lock-up and increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHR, FLHXSHRINE, FLHXS, FLHTCU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V320000·2014-06-12

    BMW Recalls 2014 R 1200 RT Motorcycles for Rear Shock Absorber Defect

    BMW is recalling 950 model year 2014 R 1200 RT motorcycles because the rear shock absorber piston rod can break, causing loss of stability and increasing crash risk.

    Product
    BMW — BMW R 1200 RT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V315000·2014-06-12

    GM Recalls 2012 Chevrolet Sonic Vehicles for Transmission Shaft Fracture Risk

    General Motors is recalling 21,567 model year 2012 Chevrolet Sonic vehicles because the transmission turbine shaft may fracture, potentially limiting speed or causing the vehicle to coast.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V325000·2014-06-12

    Hyundai Recalls 2015 Sonata Vehicles Due to Wiring Harness Defect

    Hyundai is recalling 2015 Sonata vehicles because a wiring harness defect may reduce power steering assist or prevent shifting from Park, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14206·2014-06-12

    Big Lots Recalls Wilson and Fisher Cayman Resin Wicker Ottomans

    Big Lots is recalling Wilson and Fisher brand Cayman Resin Wicker Ottomans because the center can collapse, posing a fall hazard.

    Product
    Wilson and Fisher brand Cayman Resin Wicker Ottoman
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V321000·2014-06-12

    Gulf Stream Recalls 2014 Trailers Due to Entry Step Rivet Failure Risk

    Gulf Stream is recalling 2014 Canyon Trail, Sedona, Kingsport, and Trail Master trailers because entry step rivets may fail, posing a slip and fall hazard.

    Product
    GULF STREAM — GULF STREAM SEDONA, TRAIL MASTER, CANYON TRAIL, KINGSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V317000·2014-06-12

    GM Recalls 2014 Buick LaCrosse for Wiring Splice Defect

    General Motors is recalling 2014 Buick LaCrosse vehicles because a wiring splice may corrode, causing a missing door chime and allowing windows to operate after the vehicle is off.

    Product
    BUICK — BUICK LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V327000·2014-06-12

    Stahl Recalls Modified Ford Super Duty Trucks Due to Fire Risk

    Stahl is recalling modified 2009-2014 Ford F-350, F-450, and F-550 Super Duty trucks because oil leaks from a PTO pressure switch may ignite the exhaust thermal blanket.

    Product
    FORD — FORD F-350 SD, F-550 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V318000·2014-06-12

    GM Recalls 2004-2011 Saab 9-3 Convertibles for Seat Belt Defect

    General Motors is recalling 28,789 Saab 9-3 Convertibles because the driver's seat belt retractor may break, preventing the belt from retracting properly.

    Product
    SAAB — SAAB 9-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1358-2014·2014-06-11

    Hospira Recalls Marcaine Injection Vials Due to Visible Metal Particles

    Hospira is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection because a customer complaint confirmed the presence of visible metal particles and discolored solution.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2004-2014·2014-06-11

    Dragonfly Crushed Chili Powder Recalled for Salmonella Contamination

    U.S. Trading Co. is recalling Dragonfly Brand Crushed Chili Powder because an FDA sample tested positive for Salmonella B. reilly.

    Product
    Dragonfly Brand Crushed Chili Powder, Net Wt. 6.3 oz plastic tubs. Product of Thailand UPC 7 21557-53317 8 Packed for: U.S. Trading Co., 21118 Cabot Blvd., Hayward, CA 94545
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1986-2014·2014-06-11

    Noh Foods Recalls Hawaiian Coconut Pudding Due to Undeclared Milk Allergen

    Noh Foods International of Hawaii is recalling Hawaiian Coconut Pudding because testing found high levels of undeclared milk allergen.

    Product
    Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 kg. Ingredients: Sugar, coconut "powder, corn starch, locust bean gum, carrageenan, maltodextrin. 2 oz UPC 073562000504; 4 oz UPC 07356200055
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-2006-2014·2014-06-11

    Ste Fromagere du Livradois Recalls Raclette and Montboissie Cheeses for Salmonella Risk

    Ste Fromagere du Livradois is recalling specific lots of Raclette and Montboissie cheeses due to potential Salmonella contamination.

    Product
    Montboissie du haut- Livradois Manufactured by Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrapped in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2005-2014·2014-06-11

    Ste Fromagere du Livradois Recalls Raclette and Montboissie Cheeses for Salmonella Risk

    Ste Fromagere du Livradois is recalling specific lots of Raclette and Montboissie cheeses due to potential Salmonella contamination.

    Product
    Raclette du Haut Livradois Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1706-2014·2014-06-11

    GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps

    GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.

    Product
    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1715-2014·2014-06-11

    Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.

    Product
    The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1719-2014·2014-06-11

    ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning

    ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.

    Product
    MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1357-2014·2014-06-11

    Losartan Potassium Tablets Recalled for Presence of Foreign Substance Debris

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because some bottles may contain debris swept up during cleaning.

    Product
    LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1714-2014·2014-06-11

    Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue

    Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.

    Product
    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1992-2014·2014-06-11

    Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein

    Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars due to undeclared milk protein in the chocolate coating.

    Product
    Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-1991-2014·2014-06-11

    Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein

    Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars because the chocolate coating contains undeclared milk protein.

    Product
    Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-1678-2014·2014-06-11

    Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors

    Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.

    Product
    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2014·2014-06-11

    Hospira Infusion Pumps Recalled for Door Roller Assembly Defect

    Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.

    Product
    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2014·2014-06-11

    Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1711-2014·2014-06-11

    Siemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk

    Siemens is recalling 37 AXIOM Luminos dRF diagnostic imaging systems because electrostatic discharges may trigger unintended movement, posing a danger to patients and personnel.

    Product
    AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric exam
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1686-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2014·2014-06-11

    Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.

    Product
    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1721-2014·2014-06-11

    Siemens CT Systems Recalled Due to Rubber Damper Degradation Risk

    Siemens Medical Solutions is recalling 345 CT systems because a rubber damper may degrade and break, potentially causing motor mounting plates to loosen and injuring operators or patients.

    Product
    Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral plane
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2014·2014-06-11

    Brainlab ExacTrac 5.5 Image Processing System Recalled for Plan Blending Error

    Brainlab AG is recalling ExacTrac 5.5 image processing systems because a specific workflow may generate unintended blends of separate patient treatment plans.

    Product
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2014·2014-06-11

    Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.

    Product
    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V313000·2014-06-11

    Blue Bird Recalls 2008-2013 All American School Buses for Thermostat Defect

    Blue Bird is recalling 2008-2013 All American school buses because a thermostat design flaw may cause a heater hose to rupture, allowing hot coolant to enter the passenger compartment.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1984-2014·2014-06-11

    Royal Rye Recalls Sourdough Dark Rye Bread for Undeclared Soy

    Royal Rye LLC is recalling KrustaVita Bread of Life Sourdough Dark Rye Bread due to undeclared soy. The product was distributed in Oregon and Washington.

    Product
    KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1690-2014·2014-06-11

    FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2014·2014-06-11

    Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk

    Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.

    Product
    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2014·2014-06-11

    Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1712-2014·2014-06-11

    Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty

    Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during surgery.

    Product
    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1993-2014·2014-06-11

    Greens+ Vegan Crisp Bars Recalled for Undeclared Milk Protein

    Orange Peel Enterprises is recalling Greens+ Vegan Crisp Bars because the chocolate coating contains undeclared milk protein.

    Product
    Greens+ Vegan Crisp Bars - Dark Chocolate Almond Coffee Crisp in 1.4 oz packages.
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-1718-2014·2014-06-11

    Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration

    Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical issues.

    Product
    Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1708-2014·2014-06-11

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling one lot of Monoswift PGCL absorbable sutures because they failed to meet USP minimum tensile strength requirements.

    Product
    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2008-2014·2014-06-11

    Rockman Raw Peanuts Recalled for Mold and Missing Allergen Labeling

    Rockman Company USA is recalling raw peanuts due to mold contamination and missing allergen, nutrition, and ingredient information.

    Product
    Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as "PEANUT" on packaging. Product labeling reads in part: "ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1676-2014·2014-06-11

    Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues

    Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.

    Product
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1694-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2014·2014-06-11

    Bayer Medrad Continuum MR Infusion System Recall for Damaged Locking Pins

    Bayer is recalling non-wireless Medrad Continuum MR Infusion Systems shipped before March 2008 due to potentially damaged locking pins in the bracket.

    Product
    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2014·2014-06-11

    Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage

    Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.

    Product
    Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2014·2014-06-11

    Siemens Ysio Systems Recalled for Potential Unintended Radiation Release

    Siemens is recalling 433 Ysio radiographic systems because excessive cleaning liquid usage may cause a short circuit, leading to unintended radiation release.

    Product
    Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2014·2014-06-11

    Philips CT Scanners Recalled for Disengaged Service Latch

    Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.

    Product
    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2014·2014-06-11

    Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination

    Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.

    Product
    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtroni
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1699-2014·2014-06-11

    Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections

    Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.

    Product
    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2014·2014-06-11

    LAP Laser Software Recall Due to Incorrect Patient Marking Instructions

    LAP of America is recalling CARINAsim and CARINAiso laser software manuals due to errors that may cause incorrect patient marking.

    Product
    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1702-2014·2014-06-11

    Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.

    Product
    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2014·2014-06-11

    Integra Licox Test Kit Recall for Erroneous Calibration Messages

    Integra LifeSciences is recalling Licox Test Kits that may display false calibration failure messages or out-of-range results when used with specific PtO2 monitors.

    Product
    Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific elec
    Category
    Medical Device
    Distribution
    7 states

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