The Recall Desk

Archive

September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical
15
Severe
184
High
234
Moderate
81
Low
16

Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

401–500 of 530

  • ModerateFDA (Devices)·Z-2139-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 30 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the ves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1872-2013·2013-09-11

    Greenland Trading Recalls El Basham Apricot Paste for Missing English Labeling

    Greenland Trading Corp is recalling El Basham Apricot Dried Paste because the product does not declare its identity in English. The recall covers 100 cases distributed to five states.

    Product
    El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic.
    Category
    Food
    Distribution
    5 states
  • LowFDA (Food)·F-1869-2013·2013-09-11

    La Terra Fina Spinach Artichoke Dip Recalled for Labeling Error

    La Terra Fina is recalling one lot of Spinach Artichoke and Parmesan Dip because the label displays the ingredient and nutrition information for Caramelized Onion Dip.

    Product
    Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587
    Category
    Food
    Distribution
    4 states
  • LowFDA (Devices)·Z-2131-2013·2013-09-11

    Copan WASP Instrument Recalled for Software Upgrade to Prevent Table Rotation

    Copan Italia is recalling 63 WASP instruments to upgrade software and eliminate a very low risk of the broth table rotating while the door is open.

    Product
    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-1875-2013·2013-09-11

    Justin's Nut Butter Recalled for Foreign Metallic Fragments

    Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.

    Product
    Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E050000·2013-09-10

    Sure Power Recalls Electrical Components Due to Fire Risk

    Sure Power is recalling battery equalizers and DC-DC converters because a potting compound can conduct electricity and cause fires.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V413000·2013-09-10

    Open Range Travel Trailer Recall for Jamming Deadbolt Locks

    Open Range is recalling 2009-2013 travel trailers because a defect in the deadbolt lock may jam, potentially trapping occupants inside the vehicle.

    Product
    OPEN RANGE — OPEN RANGE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13278·2013-09-10

    Eco-Novelty Recalls Jumbo Cosmo Beads Toys Due to Ingestion Hazard

    Eco-Novelty is recalling Jumbo Size and Jumbo Multipurpose Cosmo Beads toys because the water-absorbing beads can cause intestinal obstructions if swallowed by children.

    Product
    Water-absorbing polymer beads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V414000·2013-09-10

    Circle D Trailers Recalled for Door Lock Jamming Hazard

    Circle D is recalling 2006-2013 horse and multipurpose trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.

    Product
    CIRCLE D — CIRCLE D BHST, GNMPT, GNST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V411000·2013-09-10

    Team Spirit Trailers Recall 2006-2013 Models Due to Door Lock Jamming Risk

    Team Spirit is recalling 2006-2013 enclosed cargo trailers because a defect in the deadbolt lock could jam, potentially trapping occupants inside the vehicle.

    Product
    TEAM SPIRIT — TEAM SPIRIT TSDPL, TSPL, TSCDTS, TSCFTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V410000·2013-09-09

    Goshen Coach Recalls 2009-2010 Buses Due to Fire Risk

    Goshen Coach is recalling 709 model year 2009 and 2010 buses because voltage spikes may damage door header circuit boards, increasing the risk of fire.

    Product
    GOSHEN — GOSHEN WOLVERINE, GC II, PACER II, SENTINEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V406000·2013-09-09

    Micro Bird Recalls 2013 G5 School Buses for Ceiling Panel Defect

    Micro Bird is recalling 2013 G5 school buses because improperly glued ceiling panels may separate in a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E051000·2013-09-09

    Maxzone Recalls DEPO Headlamps for Ford F-150 Trucks

    Maxzone is recalling DEPO-brand replacement headlamps for 2004-2008 Ford F-150 trucks because moisture inside the lens may reduce visibility and increase crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V415000·2013-09-09

    Kingston Recalls Horse Trailers With Potentially Jamming Door Locks

    Kingston is recalling 2006-2013 horse trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    KINGSTON — KINGSTON BELVEDERE II, BRUNSWICK, BEDFORD, WINDSOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V519000·2013-09-09

    Play-Mor Trailers Recall 2006-2013 Models Due to Door Lock Defect

    Play-Mor Trailers is recalling 2006-2013 travel trailers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    PLAY-MOR — PLAY-MOR SPORTSTER, PLAY-MOR, MOTORSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V408000·2013-09-06

    Eldorado Recalls 2010 Buses Due to Door Header Fire Risk

    Eldorado is recalling 2010 Aerotech, Aero Elite, and Aerolite buses because voltage spikes in door headers may cause overheating and fire.

    Product
    ELDORADO — ELDORADO AERO ELITE, AEROLITE, AEROTECH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V404000·2013-09-06

    Homesteader Recalls 2006-2010 Trailers Due to Door Lock Jamming Risk

    Homesteader is recalling 2006-2010 enclosed cargo and horse trailers because a key removal issue may jam the deadbolt, potentially trapping occupants inside.

    Product
    HOMESTEADER — HOMESTEADER HORSE TRAILER, ENCLOSED CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13277·2013-09-06

    Crosman Recalls Air Pistols Due to Explosion Hazard

    Crosman is recalling specific air pistol models because they can explode at high temperatures, posing a risk of serious injury to users.

    Product
    Air pistols
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V405000·2013-09-06

    Suzuki Recalls Grand Vitara and SX4 for Air Bag Sensor Defect

    Suzuki is recalling 2006-2011 Grand Vitara and 2007-2011 SX4 vehicles because the front passenger air bag sensor may fail, causing the air bag to deploy regardless of occupant size.

    Product
    SUZUKI — SUZUKI SX4, GRAND VITARA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V403000·2013-09-05

    Freightliner Cascadia Trucks Recalled for Brake Caliper Bolt Torque Issues

    Daimler Trucks North America is recalling 2014 Freightliner Cascadia trucks because brake caliper mounting bolts may be incorrectly torqued, potentially leading to reduced brake effectiveness.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V401000·2013-09-05

    Western Star 4900 Recalled for Seatbelt Anchor Misalignment

    Daimler Trucks North America is recalling 2009-2014 Western Star 4900 trucks because a misaligned B-pillar hole may prevent seatbelts from restraining occupants properly in a crash.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V402000·2013-09-05

    ShowHauler Motorhomes Recalled for Door Lock Jamming Risk

    ShowHauler is recalling 2006-2013 motorhomes because the door lock may jam, potentially trapping occupants inside the vehicle.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1854-2013·2013-09-04

    Heeren Brothers Recalls Athena Cantaloupes Due to Listeria Contamination

    Heeren Brothers Produce is recalling Athena cantaloupes sold in Michigan after FDA testing found Listeria monocytogenes contamination.

    Product
    Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1852-2013·2013-09-04

    Buurma Farms Cilantro Recalled Due to Listeria monocytogenes Contamination

    Buurma Farms is recalling fresh cilantro after a customer reported a positive Listeria monocytogenes test result from the Michigan Department of Agriculture.

    Product
    Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-921-2013·2013-09-04

    Bethel 30 capsules recalled for undeclared active ingredients

    Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.

    Product
    Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-922-2013·2013-09-04

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

    Hospira is recalling 264,432 bags of 0.9% Sodium Chloride Injection because the product may contain fibrous material.

    Product
    0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-919-2013·2013-09-04

    Rugby Enteric Coated Aspirin 81 mg Recalled for Labeling Error

    Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg due to a label mix-up where one bottle contained Acetaminophen 500 mg.

    Product
    ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-920-2013·2013-09-04

    Fresenius Kabi Recalls Magnesium Sulfate Injection Due to Glass Particulates

    Fresenius Kabi is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% due to the presence of glass particulate matter.

    Product
    Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V396000·2013-09-04

    Toyota Recalls 2006-2010 Highlander and Lexus RX Hybrids for Inverter Defect

    Toyota is recalling 2006-2010 Highlander and 2006-2008 Lexus RX hybrids because a defective inverter component may cause the vehicle to stall unexpectedly while driving.

    Product
    TOYOTA — TOYOTA, LEXUS HIGHLANDER HYBRID, RX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2055-2013·2013-09-04

    Zimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor

    Zimmer, Inc. is recalling 771 units of the Trabecular Metal Reverse Shoulder Glenosphere Distractor due to potential mechanical failure if used without proper lubrication.

    Product
    00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1851-2013·2013-09-04

    Whole Foods Recalls Morbier Cheese Due to Listeria Risk

    Whole Foods Market is recalling specific varieties of Trois Comtois Morbier cheese due to potential Listeria monocytogenes contamination linked to a French supplier recall.

    Product
    Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market
    Category
    Food
    Distribution
    15 states
  • SevereNHTSA·13V395000·2013-09-04

    Toyota Recalls Lexus Vehicles for Engine Component Bolt Failure Risk

    Toyota is recalling specific Lexus GS 350, IS 350, and IS 350C vehicles because engine bolts may loosen, potentially causing the engine to stop while driving.

    Product
    LEXUS — LEXUS IS 350, GS 350, IS 350C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1850-2013·2013-09-04

    Les 3 Comtois Recalls Morbier Cheese Due to Listeria

    Les 3 Comtois is recalling 83 cases of Morbier cheese distributed in California, Illinois, and Wisconsin because FDA analysis detected Listeria monocytogenes.

    Product
    Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1853-2013·2013-09-04

    See's Candies Recalls Dark Chocolate Blueberries Due to Missing Milk Labeling

    See's Candies is recalling Dark Chocolate Blueberries because milk was omitted from the ingredient list. The product was distributed in the US, Hong Kong, and Taiwan.

    Product
    See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-918-2013·2013-09-04

    Avastin Syringes Recalled for Sterility Concerns and Eye Infection Reports

    Clinical Specialties Compounding Pharmacy is recalling Avastin syringes due to sterility assurance issues and reports of eye infections.

    Product
    Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2067-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2077-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-923-2013·2013-09-04

    Novocol Recalls Subpotent Lidocaine and Epinephrine Dental Injection Lots

    Novocol is recalling two lots of Lidocaine 2% with Epinephrine 1:100,000 injection because the epinephrine component may be subpotent.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2130-2013·2013-09-04

    Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks

    Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.

    Product
    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-925-2013·2013-09-04

    Nexus Pharmaceuticals Recalls Benztropine Mesylate Injection Due to Glass Particulates

    Nexus Pharmaceuticals is recalling 46,185 vials of Benztropine Mesylate Injection due to the presence of glass delamination flakes.

    Product
    Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2097-2013·2013-09-04

    Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach

    Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.

    Product
    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2094-2013·2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2056-2013·2013-09-04

    Integra Leyla Ball Joint Clamp Recalled for Potential Instability

    Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.

    Product
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2072-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2115-2013·2013-09-04

    GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise

    GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2013·2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2076-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2109-2013·2013-09-04

    Roche Recalls ACCU-CHEK FastClix Lancing Devices Due to Needle Retraction Defect

    Roche Diagnostics is recalling 36,332 ACCU-CHEK FastClix Lancing Devices because the needle may not fully retract after use, posing a puncture risk.

    Product
    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2079-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2091-2013·2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure

    Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2013·2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1856-2013·2013-09-04

    Whole Foods Recalls Sour Cherry Crostata for Unlabeled Egg Allergen

    Whole Foods Market is recalling Sour Cherry Crostata pies because egg wash is used in the product but is not listed on the ingredient list or allergen statement.

    Product
    Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2095-2013·2013-09-04

    Siemens Recalls Linear Accelerator Tabletops Due to Screw Breakage Risk

    Siemens is recalling specific linear accelerator tabletops because manufacturing errors may cause screws to break off, potentially affecting patient safety.

    Product
    PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2068-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2080-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1855.2013·2013-09-04

    Quesos Vaca Negra cheese recalled for E. coli test results

    Quesos Vaca Negra, Inc. is recalling specific cheese wheels in Puerto Rico after positive test results for generic E. coli.

    Product
    "***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1849-2013·2013-09-04

    Tres Leches cake recalled for undeclared soy oil allergen

    D'Aqui Manufacturing Products Corp. is recalling Tres Leches cakes sold in Puerto Rico due to undeclared soy oil.

    Product
    Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***"; 2) "****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2105-2013·2013-09-04

    Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue

    Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.

    Product
    Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2013·2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall

    Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2013·2013-09-04

    McKesson Anesthesia-Rx Software Recall Due to System Interruption

    McKesson Technologies is recalling 106 Anesthesia-Rx units because the system became temporarily unavailable during use.

    Product
    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2073-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2069-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis

    Waldemar Link is recalling nine trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2098-2013·2013-09-04

    GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations

    GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.

    Product
    GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2113-2013·2013-09-04

    DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility

    DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.

    Product
    DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2013·2013-09-04

    Respironics V1000 Ventilator Recalled Due to Display Backlight Interruption

    Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.

    Product
    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2013·2013-09-04

    Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect

    Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.

    Product
    Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2092-2013·2013-09-04

    Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.

    Product
    VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V399000·2013-09-04

    Aliner Travel Trailer Recall for Door Lock Jamming Risk

    Columbia Northwest is recalling 2006-2013 Aliner travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    ALINER — ALINER TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2013·2013-09-04

    GE Healthcare Recalls Patient Data Modules Due to Signal Noise

    GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2013·2013-09-04

    GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise

    GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.

    Product
    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2013·2013-09-04

    Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure

    Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.

    Product
    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1857-2013·2013-09-04

    Whole Foods Recalls Blueberry Crostata for Unlabeled Egg Allergen

    Whole Foods Market is recalling Blueberry Crostata pies because egg wash is used in the product but is not listed on the ingredient or allergen statement.

    Product
    Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) UPC: 0216733009993 Whole Foods Market Inc., Emeryville, CA 94608
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2054-2013·2013-09-04

    Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant

    Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.

    Product
    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-settin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·13V400000·2013-09-04

    Winnebago Recalls 2013-2014 Motorhomes Due to Child Seat Tether Defect

    Winnebago is recalling 2013-2014 Aspect and Itasca Cambria motorhomes because the child seat tether is mounted improperly, which may fail to protect occupants in a crash.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA ASPECT, CAMBRIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-926-2013·2013-09-04

    Hospira Recalls Ketorolac Tromethamine Injections Due to Sterility Concerns

    Hospira, Inc. is recalling 345,800 vials of Ketorolac Tromethamine Injection due to a lack of assurance of sterility caused by loose or missing crimps on fliptop vials.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2107-2013·2013-09-04

    SpineNet Bone Marrow Aspiration Needle Kit Recalled for Lack of FDA Clearance

    SpineNet is recalling 100 units of Bone Marrow Aspiration Needle Kits because they were marketed for use with the SpineNet ACC device without FDA clearance or approval.

    Product
    SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2062-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2078-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-917-2013·2013-09-04

    Actavis Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

    Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed to meet dissolution specifications.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2013·2013-09-04

    Siemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error

    Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.

    Product
    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to dete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1858-2013·2013-09-04

    Daily Chef Tropical Fruit & Nut Blend Recalled for Undeclared Dyes

    Ann's House of Nuts is recalling Daily Chef Tropical Fruit & Nut Blend because it contains undeclared Yellow #5 and #6 dyes.

    Product
    Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716.
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2051-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2013·2013-09-04

    Fresenius 2008 MeDS Pump Recalled for Venofer Dosage Accuracy Issues

    Fresenius Medical Care is recalling 132 MeDS pumps used to administer Venofer during hemodialysis because the device may not meet dosage accuracy requirements.

    Product
    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2013·2013-09-04

    3M ESPE Recalls Unitek Primary Stainless Steel Crowns for Defective Edges

    3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.

    Product
    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2013·2013-09-04

    Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions

    Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2046-2013·2013-09-04

    Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling

    Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.

    Product
    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2013·2013-09-04

    Life Technologies Recalls HSV-2 Primers Due to Amplification Failure

    Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.

    Product
    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-924-2013·2013-09-04

    Teva Recalls Propranolol Hydrochloride Tablets Due to Weight Specification Failures

    Teva Pharmaceuticals is recalling specific lots of Propranolol Hydrochloride 10 mg tablets because some may not meet weight specifications.

    Product
    Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
    Category
    Drug
    Distribution
    Distributed nationwide

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