The Recall Desk

Archive

July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical
104
Severe
251
High
252
Moderate
109
Low
25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 34% are Severe.

Which agencies issued them

601–700 of 741

  • ModerateFDA (Devices)·Z-1635-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Orthopedic Drill Bits

    Surgical Instrument Service And Savings, Inc. is recalling 10 orthopedic drill bits because the sterile barrier seal was compromised, allowing product to fall out of the pouch.

    Product
    - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1643-2013·2013-07-10

    Surgical Instrument Service Recalls ENDOPATH Trocars Due to Compromised Sterile Seals

    Surgical Instrument Service and Savings, Inc. is recalling 259 ENDOPATH trocars and accessories because compromised sterile seals may allow product to fall out of the pouch.

    Product
    - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920W Event Recorders

    Braemar Inc. is recalling 10,785 lithium thionyl battery packs used with ER920W wireless event monitors following a battery incident that caused no patient injury.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1660-2013·2013-07-10

    Merit Medical Systems Recalls Custom Angio Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 134 custom angio kits because a missing seal may compromise the sterility of the hand controller sheaths.

    Product
    Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are h
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1638-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Compression Sleeves Due to Seal Failure

    Surgical Instrument Service And Savings, Inc. is recalling 229 units of compression sleeves and garments because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Expr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1583-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Bedtime Due to Swallowing Difficulty

    Florida Nutri Labs is recalling 4HB Stack Bedtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1658-2013·2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.

    Product
    ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 13 Medical Devices Due to Seal Compromise

    Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices because compromised seals may allow products to fall out of sterile pouches.

    Product
    -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1582-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Mealtime Due to Coating Defect

    Florida Nutri Labs is recalling 4HB Stack Mealtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2013·2013-07-10

    Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal

    Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.

    Product
    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2013·2013-07-10

    ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color

    ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.

    Product
    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1628-2013·2013-07-10

    Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise

    Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 1224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1623-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Carpal Tunnel Release Blades

    Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially allowing product to fall out of the pouch.

    Product
    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (Wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1629-2013·2013-07-10

    Surgical Instrument Service Recalls Re-New II Endocut Scissor Tips

    Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.

    Product
    - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise

    Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1641-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Arthroscopic Cannulas Due to Seal Defect

    Surgical Instrument Service And Savings, Inc. is recalling 73 arthroscopic cannulas because a compromised seal may allow the product to fall out of the sterile pouch.

    Product
    - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1639-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter

    Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.

    Product
    - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 907 Arthroscopic Instruments

    Surgical Instrument Service And Savings, Inc. is recalling 907 arthroscopic instruments because compromised sterile seals may allow product to fall out of the pouch.

    Product
    - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-631-2013·2013-07-10

    Pfizer Recalls Prempro Tablets Due to Dissolution Specification Failures

    Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.

    Product
    Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1581-2013·2013-07-10

    Alymaq Extra Fine Granulated Sugar Recalled for Potential Plastic Fragments

    Alymaq Inc is recalling 770 bags of Extra Fine Granulated Sugar AIB in Ohio due to the potential presence of plastic fragments.

    Product
    ALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE. Multi-wall polyethylene lined bag. 55 bags per pallet.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-1662-2013·2013-07-10

    BD MAX Instrument Recall for Non-Compliant Electrical Power Module

    Becton Dickinson is recalling 71 BD MAX instruments because the installed electrical power module does not meet industry standards as labeled.

    Product
    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research setti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-630-2013·2013-07-10

    Pfizer Recalls Prempro Tablets Due to Dissolution Specification Failures

    Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.

    Product
    Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V302000·2013-07-09

    Spartan Motors Recalls Transit Bus Chassis Cabs for Fuel Pump Defect

    Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because a faulty harness may cause the fuel pump to shut off, leading to engine stalling.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V300000·2013-07-08

    Mitsubishi Recalls 2013 Outlander Sport for Front Suspension Weld Defect

    Mitsubishi is recalling 2013 Outlander Sport vehicles due to a defective front stabilizer link weld that may damage tires or brake hoses, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V297000·2013-07-08

    Honda Recalls 2013 Accord Vehicles for Fuel Tank Seal Defect

    Honda is recalling specific 2013 Accord vehicles because a fuel tank neck defect may cause a fuel leak, increasing the risk of fire.

    Product
    HONDA — HONDA ACCORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E037000·2013-07-08

    Kuryakyn Recalls Handlebar Risers for Honda Goldwing Motorcycles

    Kuryakyn is recalling handlebar risers for Honda Goldwing GL1800s because mounting screws may break, potentially causing the handlebars to separate and increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V294000·2013-07-05

    TCI Recalls Two School Bus Models Due to Wheelchair Lift Fire Risk

    TCI is recalling two school bus models because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    TCI — TCI DW6159RLSST, SC159DSFP600
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E036000·2013-07-05

    Thermo King Recalls Precedent S-600 Refrigeration Units Due to Bracket Defect

    Thermo King is recalling Precedent S-600 transportation refrigeration units manufactured in April and May 2013 because the lifting bracket may break, posing a risk of injury if the unit falls.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V296000·2013-07-05

    Ameritrans M2 Series Bus Recalled for Wheelchair Lift Fire Risk

    Ameritrans is recalling one 2013 M2 Series bus because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    AMERITRANS — AMERITRANS M2 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1570-2013·2013-07-03

    Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery

    Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-612-2013·2013-07-03

    Hospira Recalls 70% Dextrose Injection Due to Possible Leaking Bags

    Hospira is voluntarily recalling 14,706 units of 70% Dextrose Injection USP due to possible leaking bags that may compromise sterility.

    Product
    70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1569-2013·2013-07-03

    BIMBO Bakeries Recalls Earthgrains Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling Earthgrains Food Service Hamburger Buns Wheat with Oat due to possible metal fragments from a faulty manufacturing part.

    Product
    Food Service Hamburger Buns Wheat with Oat 12 CT Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·13V293000·2013-07-03

    Dutchmen Recalls 2013-2014 Travel Trailers Due to Propane Hose Fire Risk

    Dutchmen is recalling 2013-2014 Aspen, Coleman, and Dutchmen travel trailers because heat from the range burner may melt the propane supply hose, increasing the risk of a fire.

    Product
    ASPEN TRAIL — ASPEN TRAIL, COLEMAN, DUTCHMEN TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-614-2013·2013-07-03

    Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 5% Dextrose Injection USP bags due to possible leaking that compromises sterility assurance.

    Product
    5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-617-2013·2013-07-03

    Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns

    Hospira is voluntarily recalling 0.9% Sodium Chloride Irrigation bags due to possible leaking that compromises sterility.

    Product
    0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-611-2013·2013-07-03

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 0.9% Sodium Chloride Injection in flexible containers due to possible leaking bags that may compromise sterility.

    Product
    0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1586-2013·2013-07-03

    Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor

    Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.

    Product
    DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1575-2013·2013-07-03

    See's Candies Recalls Milk Raisins for Potential Nut and Egg Residue

    See's Candies is recalling 5,814 pounds of Milk Raisins because they may contain undeclared nut or egg residues. The product was sold in 240 stores and 10 licensees nationwide.

    Product
    See's Milk Raisins: Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in S
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1558-2013·2013-07-03

    BIMBO Bakeries Recalls Colonial Seeded Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling Colonial 12 Seeded Enriched Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Colonial 12 Seeded Enriched Buns Sara Lee, Downers, Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-616-2013·2013-07-03

    Hospira Recalls 20% Dextrose Injection Due to Possible Leaking Bags

    Hospira is voluntarily recalling 20% Dextrose Injection, USP, due to possible leaking bags that may compromise sterility.

    Product
    20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1559-2013·2013-07-03

    BIMBO Bakeries Recalls Great Value Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling Great Value 8 Jumbo Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Great Value 8 Jumbo Hamburger Buns Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·13V292000·2013-07-03

    Toyota Recalls 2012 Yaris Vehicles for Power Steering Defect

    Toyota is recalling 2012 Yaris vehicles because a relay in the power steering system could short-circuit, disabling steering assistance and increasing crash risk.

    Product
    TOYOTA — TOYOTA YARIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1554-2013·2013-07-03

    Bimbo Bakeries Recalls Earthgrains Hot Dog Buns Due to Metal Fragments

    Bimbo Bakeries USA is recalling 8,572 units of Earthgrains Hot Dog Buns due to possible metal fragments caused by a faulty manufacturing part.

    Product
    Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1560-2013·2013-07-03

    BIMBO Bakeries USA Recalls Kerns Beef Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling 812 cases of Kerns Beef Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Kerns Beef Buns - 12 count Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1572-2013·2013-07-03

    Bimbo Bakeries Recalls Hamburger Buns Due to Possible Metal Fragments

    Bimbo Bakeries USA is recalling food service hamburger buns due to the possible presence of metal fragments caused by a faulty manufacturing part.

    Product
    Hamburger Buns Bimbo Bakeries USA 255 Business Center Dr. Horsham, PA 19044 Food Service Hamburger Buns, Seeded and Unseeded, all counts:
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-615-2013·2013-07-03

    Hospira Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-618-2013·2013-07-03

    Hospira Recalls 1.5% Glycine Irrigation Due to Sterility Concerns

    Hospira is voluntarily recalling 1.5% Glycine Irrigation, USP, 3000 mL, due to possible leaking bags that may compromise sterility.

    Product
    1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1568-2013·2013-07-03

    BIMBO Bakeries Recalls Whole Wheat Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling 12-count packs of Foodservice 100% Whole Wheat Hamburger Buns due to the possible presence of metal fragments caused by a faulty manufacturing part.

    Product
    Foodservice 100% Whole Wheat Hamburger Buns - 12 Ct Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-613-2013·2013-07-03

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1564-2013·2013-07-03

    Sara Lee Classic White Hamburger Buns Recalled for Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Classic White Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Sara Lee Classic White 12 Hamburger Buns Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1577-2013·2013-07-03

    BD SafetyGlide Syringe Tray Recalled for Needle Mechanism Failure

    Becton Dickinson is recalling 1,326,000 units of BD SafetyGlide Allergy syringe trays because the needle safety mechanism may disengage.

    Product
    BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2013·2013-07-03

    Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints

    Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.

    Product
    Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2013·2013-07-03

    Sunbeam Hamburger Buns Recalled for Possible Metal Fragments

    BIMBO Bakeries USA is recalling Sunbeam hamburger buns due to possible metal fragments from a faulty manufacturing part at a North Carolina bakery.

    Product
    Sunbeam 12 Enriched Hamburger Buns and Sunbeam 12 (Seeded) Hamburger Buns Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1590-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2013·2013-07-03

    Baxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.

    Product
    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2013·2013-07-03

    Baxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in rupture complaints. The devices are used for intravenous medication administration.

    Product
    Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2013·2013-07-03

    Prism Medical C-Series Carry Bar Recalled for Improper Installation

    Prism Medical Services USA is recalling 1,131 C-Series Carry Bars due to improper installation. The firm is replacing them with a plastic insert and metal insert carry bar.

    Product
    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2013·2013-07-03

    RF Technologies Recalls Code Alert Advanced 4-Way Care Solution Due to Firmware Error

    RF Technologies is recalling 167 Code Alert Advanced 4-Way Care Solution units because a firmware error may delay alarm transmission to the server.

    Product
    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2013·2013-07-03

    Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect

    Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.

    Product
    Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1593-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2013·2013-07-03

    Philips CT Scanners Recalled for Patient Selection and Scan Safety Issues

    Philips Medical Systems is recalling 50 CT scanners due to a software defect that can cause incorrect patient names to appear on exam pages and allow clinical scans to start during anti-virus scans.

    Product
    Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2013·2013-07-03

    Maquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors

    Maquet is recalling specific pediatric arterial cannula packs because they may contain incorrectly sized connectors. The recall affects 100 units distributed in the US and internationally.

    Product
    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1565-2013·2013-07-03

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Leaking Pouches

    Baxter Healthcare is recalling 629,280 units of MiniCap with Povidone-Iodine solution for dialysis due to leaking pouches. The recall is voluntary and nationwide.

    Product
    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-619-2013·2013-07-03

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira is voluntarily recalling specific lots of 0.9% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2013·2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific s
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1575-2013·2013-07-03

    Medtronic Recalls INDURA 1P Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling INDURA 1P Intrathecal Catheters because the previous connector design has a greater potential for misalignment and occlusion.

    Product
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Conte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2013·2013-07-03

    Roche Recalls CoaguChek XS Plus Systems Due to Potential Test Errors

    Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2013·2013-07-03

    Sara Lee Bakery Buns Recalled for Possible Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Hearty & Delicious White Bakery Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    8 Bakery Buns Sara Lee Hearty & Delicious White Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1570-2013·2013-07-03

    BIMBO Bakeries Recalls Foodservice Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling 5,326 units of Foodservice Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Foodservice Hamburger Buns - 12 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1609-2013·2013-07-03

    Baxter Recalls Infusor SV Elastomeric Infusion Devices Due to Leak Complaints

    Baxter Healthcare is recalling 601,230 Infusor SV Elastomeric Infusion Devices due to increased complaints of leaks at the distal male Luer and Luer cap.

    Product
    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2013·2013-07-03

    Loma Vista Medical Recalls TRUE Dilatation Balloon Valvuloplasty Catheters

    Loma Vista Medical is recalling TRUE Dilatation Balloon Valvuloplasty Catheters because they deflate slower than the specified maximum of 10 seconds.

    Product
    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·13235·2013-07-03

    H-E-B Recalls Outdoor Solutions Hammock with Sunshade Due to Fall Hazard

    H-E-B is recalling Outdoor Solutions Hammocks with Sunshades because the seam can tear, posing a fall hazard. Consumers should stop using the product and contact H-E-B for a refund.

    Product
    Outdoor Solutions Hammock with Sunshade
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2013·2013-07-03

    BIMBO Bakeries Recalls Earthgrains Hamburger Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling 741 cases of Earthgrains Foodservice Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Foodservice Hamburger Buns - 20 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1607-2013·2013-07-03

    Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

    Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.

    Product
    Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1604-2013·2013-07-03

    Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints

    Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The company states that product and process improvements have since reduced the complaint rate.

    Product
    Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2013·2013-07-03

    Roche Recalls CoaguChek XS Pro Systems Due to Potential Test Errors

    Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.

    Product
    CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1563-2013·2013-07-03

    Sara Lee Bakery Buns Recalled for Possible Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Hearty & Delicious 100% Whole Wheat Bakery Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Sara Lee Hearty & Delicious 100% Whole Wheat 8 Bakery Buns Sara lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1591-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1561-2013·2013-07-03

    Kroger White Jumbo Hamburger Buns Recalled for Metal Fragment Risk

    BIMBO Bakeries USA is recalling Kroger White Jumbo Hamburger Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Kroger White Jumbo Hamburger Buns - 8 Buns Distributed By: The Kroger Co. Cincinnati, Ohio 45202
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1589-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1576-2013·2013-07-03

    Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.

    Product
    Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2013·2013-07-03

    Baxter Recalls Regional Analgesia Infusor Systems Due to Rupture Complaints

    Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.

    Product
    Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors

    Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2013·2013-07-03

    Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk

    Medtronic is recalling Sutureless Pump Connector Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2013·2013-07-03

    Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the Syn
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1608-2013·2013-07-03

    Cordis RadialSource Spring Wire Transradial Access Kit Recalled for Undersized Tip

    Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.

    Product
    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1601-2013·2013-07-03

    Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints

    Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.

    Product
    Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2013·2013-07-03

    Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits

    Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2013·2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery

    Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential Test Errors

    Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2013·2013-07-03

    Baxter Recalls Basal/Bolus Infusors Due to Rupture Complaints

    Baxter Healthcare is recalling 3.2 million Basal/Bolus Infusors due to increased rupture complaints. The devices are used for intravenous medication administration.

    Product
    Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide

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