The Recall Desk

Archive

April 2013 recalls

399 recalls were announced in April 2013.

What the numbers show

Critical
21
Severe
67
High
142
Moderate
128
Low
41

Of the 399 recalls this month scored against our rubric, 5% are Critical, 17% are Severe.

101–200 of 399

  • ModerateFDA (Devices)·Z-1118-2013·2013-04-24

    Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.

    Product
    Clinical Chemistry Phenobarbital, list number 1E08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2013·2013-04-24

    Synvasive Oxford Partial Knee Resection Blades Recalled for Incorrect Component

    Synvasive Technology is recalling 100 kits of Oxford Partial Knee Resection Procedure 3 Packs because they contained the incorrect surgical blade.

    Product
    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2013·2013-04-24

    Bacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure

    Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.

    Product
    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2013·2013-04-24

    Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions

    Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.

    Product
    IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2013·2013-04-24

    Alere Cholestech LDX ALT AST Test Cassette Recalled for Humidity Impact

    Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.

    Product
    Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2013·2013-04-24

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

    Product
    VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2013·2013-04-24

    Synvasive Reciprocating Saw Blades Recalled for Labeling Errors

    Synvasive Technology is recalling 3,442 reciprocating saw blades due to incorrect labeling regarding blade type, expiration dates, and compatible power systems.

    Product
    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an ort
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2013·2013-04-24

    Integra XKnife Software Versions 5.0.1 and 5.0.2 Recalled for Beam Plan Error

    Integra LifeSciences Corp. is recalling XKnife software versions 5.0.1 and 5.0.2 due to a software error that may occur when transmitting beam plans.

    Product
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1121-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1336-2013·2013-04-24

    Trader Joe's Mediterranean Hummus Recalled for Foreign Material

    Two Chefs On A Roll is recalling Trader Joe's Mediterranean Hummus Snack Packs because they may contain small pieces of food-grade equipment material.

    Product
    Trader Joe's Mediterranean Hummus Snack Pack with Pita Chips 8 oz., 24 units/case, SKU 97136.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1318-2013·2013-04-24

    Cypress Grove Humboldt Fog Goat Cheese Recalled for Incorrect Ingredient Labeling

    DPI Specialty Foods is recalling Cypress Grove Humboldt Fog Goat Cheese because it was labeled as containing cultured raw cow's milk instead of pasteurized goat milk.

    Product
    Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1329-2013·2013-04-24

    Trader Joe's Hummus Dip Recalled for Foreign Material Contamination

    Two Chefs On A Roll is recalling Trader Joe's Hummus Dip because it may contain small pieces of food grade equipment.

    Product
    Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-252-2013·2013-04-24

    Pfizer Recalls Levoxyl Tablets Due to Chemical Odor Contamination

    Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-248-2013·2013-04-24

    Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    Actavis South Atlantic LLC is recalling 555,672 bottles of buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed USP dissolution test requirements.

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1125-2013·2013-04-24

    Instrumentation Industries Recalls Manual Jet Ventilators for Updated Directions

    Instrumentation Industries is recalling specific manual jet ventilators and accessories to replace previously distributed Directions for Use with updated versions.

    Product
    Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet
    Category
    Medical Device
    Distribution
    44 states
  • LowFDA (Devices)·Z-1148-2013·2013-04-24

    Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk

    Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.

    Product
    IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-264-2013·2013-04-24

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Discoloration

    Lupin Pharmaceuticals is recalling Suprax (cefixime) oral suspension bottles because the product may not meet color specifications after reconstitution.

    Product
    Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·13E020000·2013-04-23

    C. E. White Recalls School Bus Flip Seats for Pinch Hazard

    C. E. White is recalling specific school bus flip seats installed between 2005 and 2013 because the lower frame gap can pinch the toes or feet of passengers in rearward seats.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V155000·2013-04-23

    Keystone Recalls 2013-2014 Recreational Trailers Due to Awning Motor Defect

    Keystone RV Company is recalling 2013-2014 recreational trailers because a damaged awning motor may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.

    Product
    KEYSTONE — KEYSTONE RAPTOR, SUMMERLAND, RESIDENCE, SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·13V156000·2013-04-23

    Triple E Recalls 2012-2013 Libero, Regency, and Unity RVs for Lighting Defect

    Triple E Recreational Vehicles is recalling 410 model year 2012-2013 Libero, Regency GT, and Unity units because the license plate light does not adequately illuminate the plate at night.

    Product
    REGENCY GT — REGENCY GT, UNITY, LIBERO GT28D, U24MB, L24CB, GT27S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E019000·2013-04-22

    Dometic Recalls Motor-Powered Awning Models Due to Injury Risk

    Dometic is recalling specific motor-powered awnings and service kits because improper installation can damage the motor, causing the awning to unfurl unexpectedly and increase the risk of injury or a crash.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V151000·2013-04-19

    Forest River Recalls 2013 Shasta Revere Trailers Due to Incorrect Tire Labels

    Forest River is recalling 173 model year 2013 Shasta Revere trailers because incorrect tire load and pressure information on labels may lead to overinflation and sudden tire failure.

    Product
    SHASTA REVERE — SHASTA REVERE SHT27DB, SHT30BH, SHT27BH, SHT27KS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V150000·2013-04-19

    Prevost Recalls Coach Buses Due to Incorrect Emergency Window Decals

    Prevost is recalling specific coach buses because emergency window decals omit a required step to open the windows, potentially increasing injury risk in a crash.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, XLII-45, H3-45 VIP, X3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1303-2013·2013-04-17

    Nashua Nutrition Recalls Proti Diet Chocolate Dream Bars for Salmonella Risk

    Nashua Nutrition is recalling Proti Diet High Protein Chocolate Dream Bars due to potential Salmonella contamination. Consumers should stop eating the product and return it to the place of purchase.

    Product
    Proti Diet High Protein Chocolate Dream Bar, is sold in 210 g packages (7 bars per package) UPC 6 21498 42238 1
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2013·2013-04-17

    Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error

    Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.

    Product
    Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult C
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1302-2013·2013-04-17

    Green Day White Melon Seeds Recalled for Undeclared Sulfites

    Domega NY International Co Ltd is recalling Green Day brand White Melon Seeds due to undeclared sulfites detected by New York State authorities.

    Product
    GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For: Domega
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1063-2013·2013-04-17

    FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units

    FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.

    Product
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1314-2013·2013-04-17

    Sage Creek Recalls Canned Apricots Due to Underprocessing and Swollen Cans

    Sage Creek Inc is recalling Hood-Crest canned apricots in light or heavy syrup due to reports of underprocessing, swollen cans, and undercooked fruit.

    Product
    Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads "HOOD-CREST APRICOTS UNPEELED HALVES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G". The back panel reads in part "*** INGREDIENTS: APRICOTS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles, Ore.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1078-2013·2013-04-17

    GE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk

    GE Healthcare is recalling Infinia Nuclear Medicine Systems because a mechanical defect could cause the detector to slide, posing a risk to patients and operators.

    Product
    GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1066-2013·2013-04-17

    Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled

    Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.

    Product
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V147000·2013-04-17

    Explorer Van Company Recalls 2013 GMC Savana and Chevrolet Express Vans

    Explorer Van Company is recalling 885 model year 2013 Explorer and Explorer Limited SE vans built on GMC Savana and Chevrolet Express chassis due to a wiring harness defect that may cause a fire.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1051-2013·2013-04-17

    GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors

    GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.

    Product
    Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1058-2013·2013-04-17

    Respironics Infant Masks Recalled Due to Incorrect Size Labeling

    Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.

    Product
    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-1312-2013·2013-04-17

    Sage Creek Recalls Canned Peaches Due to Underprocessing and Swollen Cans

    Sage Creek Inc is recalling Hood-Crest canned peaches in the Western US due to reports of underprocessed fruit and swollen or bursting cans.

    Product
    Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS:
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·13V145000·2013-04-17

    E-One Recalls Cyclone II Fire Trucks Due to Brake Fire Risk

    E-One is recalling 2011-2013 Cyclone II fire fighting vehicles because brake chambers may leak, causing brakes to drag and overheat, which could lead to a fire.

    Product
    E-ONE — E-ONE CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1313-2013·2013-04-17

    Sage Creek Recalls Canned Bartlett Pear Halves Due to Processing Defects

    Sage Creek Inc is recalling canned Bartlett pear halves in light or heavy syrup due to reports of under-processed fruit and swollen or bursting cans.

    Product
    Canned Pear Halves in Light Syrup or canned Pear Halves in Heavy Syrup. The PDP reads "HOOD-CREST HALVES BARTLETT PEARS IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G" and the back panel reads in part "***INGREDIENTS: PEARS WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The Da
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1300-2013·2013-04-17

    Nutrex Research Recalls Lipo 6 Black Ultra Concentrate Due to DMAA

    Nutrex Research is recalling Lipo 6 Black Ultra concentrate Fat Destroyer because samples contain DMAA (Methylhexanamine). The recall affects 82,417 sample packets distributed in eight states.

    Product
    Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1299-2013·2013-04-17

    NewChapter Probiotic Elderberry Recalled for Undeclared Soy Allergen

    New Chapter, Inc. is recalling 1,004 bottles of Probiotic Elderberry dietary supplements because they may contain undeclared soy.

    Product
    NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle. Dietary Supplement UPC: 7-27783-00123-8
    Category
    Food
    Distribution
    38 states
  • HighFDA (Devices)·Z-1082-2013·2013-04-17

    Physio Control Recalls LIFEPAK Defibrillators Due to Battery Depletion Risk

    Physio Control is recalling LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators because they may experience early internal battery depletion.

    Product
    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1083-2013·2013-04-17

    GE Healthcare Recalls VMX Mobile X-ray Units Due to Arm Base Casting Issue

    GE Healthcare is recalling VMX and VMX Plus mobile X-ray units because a defect in the arm base casting may impact operator or patient safety.

    Product
    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for total
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1295-2013·2013-04-17

    NatureBox Umami Almonds Recalled for Undeclared Wheat Allergen

    NatureBox is recalling 802 units of Umami Almonds because the product may contain wheat, which is not listed in the ingredient statement.

    Product
    NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the product, Product is processed and packaged by NatureBox, San Carlos, CA; NOTE: Product label DOES declare that it is "Packed in a facility
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1065-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1310-2013·2013-04-17

    Red Eagle Flour Tortillas Recalled for Undeclared Wheat Allergen

    Red Eagle Enterprises is recalling flour tortillas because they contain undeclared wheat, posing a risk to consumers with wheat allergies.

    Product
    Lite Thin Tortillas, one dozen., net wt. 15 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1071-2013·2013-04-17

    J T Posey Recalls Biothane Restraint Cuffs Due to Tensile Strength Defect

    J T Posey Company is voluntarily recalling 1,673 Biothane Restraint Cuffs because they failed to meet tensile strength specifications, posing a risk of disconnection.

    Product
    Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13171·2013-04-17

    Gerbings Recalls 12-Volt Heated Jacket Liners Due to Burn Hazard

    Gerbings is recalling about 9,900 12-volt heated jacket liners sold at Harley-Davidson dealerships and other stores because a defective wire connector can cause overheating and minor burns.

    Product
    12-volt heated jacket liners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1308-2013·2013-04-17

    Giant Eagle Cookies Recalled for Undeclared Soy Allergen

    Giant Eagle is recalling Lotsa Chocolate Chip Cookies because the labels fail to declare soy lecithin, a major allergen present in the product.

    Product
    Giant Eagle Lotsa Chocolate Chip Cookies
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1301-2013·2013-04-17

    Sunchang Ssamjang Sesame and Garlic Bean Paste Recalled for Peanut Mislabeling

    Daesang America is recalling Sunchang Ssamjang bean paste because the English label omits peanut powder, a major allergen listed in Korean.

    Product
    Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2013·2013-04-17

    Elekta Precise Treatment Table Recalled for Column Rotation Defect

    Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.

    Product
    Precise Treatment Table. To be used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2013·2013-04-17

    GE Healthcare Recalls Discovery MR750w Systems Due to Image Flip Defect

    GE Healthcare is recalling 46 Discovery MR750w 3.0T MRI systems worldwide due to a potential image flip issue that may result in incorrect anatomical localization.

    Product
    GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the stru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2013·2013-04-17

    Medtronic Recalls Paradigm Insulin Pumps Due to Cap Detachment Risk

    Medtronic is recalling Paradigm insulin infusion pumps because a drive support cap may detach and allow water to damage internal electronics.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1311-2013·2013-04-17

    Red Eagle Flour Tortillas Recalled for Undeclared Wheat

    Red Eagle Enterprises is recalling flour tortillas because they contain undeclared wheat, a major food allergen.

    Product
    Small Flour Gorditas, one dozen, net wt. 24 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1309-2013·2013-04-17

    Red Eagle Flour Tortillas Recalled for Undeclared Wheat

    Red Eagle Enterprises is recalling flour tortillas because they contain undeclared wheat, a major food allergen.

    Product
    Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1307-2013·2013-04-17

    Mikesell's Honey Barbecue Potato Chips Recalled for Gluten Free Mislabeling

    Mike-Sells Potato Chip Co is recalling Honey Barbecue flavored potato chips labeled as 'Gluten Free' due to mislabeling complaints.

    Product
    Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1305-2013·2013-04-17

    ShanTea Enlightened Mind Mate Kukicha Recalled for Salmonella Risk

    ShanTea LLC is recalling 111 cases of Enlightened Mind Mate/Kukicha tea due to potential Salmonella contamination. The product was distributed in 12 states.

    Product
    ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Drugs)·D-244-2013·2013-04-17

    GSMS Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Particulates

    GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they contain minute stainless steel particulates.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·13V146000·2013-04-17

    Navistar Recalls International Trucks Due to Sun Shade Separation Risk

    Navistar is recalling certain 2011-2013 International commercial trucks because sun shades may separate from the roof, potentially distracting the driver and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL DURASTAR, WORKSTAR, TRANSTAR, LONESTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2013·2013-04-17

    Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk

    Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.

    Product
    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1064-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1096-2013·2013-04-17

    GE Healthcare Recalls LOGIQ Ultrasound Systems Due to Potential Skin Burn Risk

    GE Healthcare is recalling LOGIQ S8 and S7 ultrasound systems equipped with the S4-10-D probe due to a potential safety issue that may cause skin burns.

    Product
    GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1061-2013·2013-04-17

    Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment

    Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.

    Product
    Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2013·2013-04-17

    Siemens Recalls Angiographic X-Ray Systems Due to Table Collision Risk

    Siemens is recalling 51 angiographic x-ray systems because a malfunction in the table vertical lift could cause a collision if obstructed by a solid object.

    Product
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2013·2013-04-17

    Thermo Fisher CO2 Incubators Recalled for Hinge Failure

    Thermo Fisher Scientific is recalling 15,567 CO2 incubators manufactured before mid-2009 because their coated metal hinges have reportedly failed in the field.

    Product
    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2013·2013-04-17

    AGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error

    AGFA Corp. is recalling IMPAX CV 7.8 SU3 software due to a design error. The product was distributed in Florida and Kentucky.

    Product
    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive v
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1296-2013·2013-04-17

    New Seasons Market Recalls Raw Cookie Product Due to Foreign Material

    New Seasons Market is recalling raw cookie product packaged in reusable totes due to the possibility of plastic or paint shavings in the containers.

    Product
    Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand wr
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1067-2013·2013-04-17

    Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error

    Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.

    Product
    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2013·2013-04-17

    AGFA IMPAX CV Software Recall for Incorrect Data Transfer

    AGFA Corp. is recalling 26 units of IMPAX CV software because baseline pulmonary capillary wedge pressure values were not correctly transferring into hospital electronic health records.

    Product
    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2013·2013-04-17

    Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity

    Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.

    Product
    Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1298-2013·2013-04-17

    Musclepharm Combat Powder Recalled for Potential Foreign Material Contamination

    F.H.G Corporation is recalling one lot of Musclepharm Combat Powder due to a packing line issue that may have introduced extraneous materials.

    Product
    MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050571
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1062-2013·2013-04-17

    Synthes Flexible Grip Recalled for Cleaning Limitations

    Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.

    Product
    Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1297-2013·2013-04-17

    MusclePharm Combat Powder Recalled for Potential Foreign Material Contamination

    F.H.G Corporation is recalling one lot of MusclePharm Combat Powder Cookies 'N' Cream due to potential foreign material contamination from a packing line issue.

    Product
    MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1076-2013·2013-04-17

    Kerr Maxcem Elite Resin Cement Recalled for Premature Polymerization

    Kerr Corporation is recalling Kerr Maxcem Elite resin cement kits and syringes because raw material causes the product to set prematurely, potentially preventing proper restoration placement.

    Product
    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2013·2013-04-17

    Toshiba CT System Recalled for Software Error in Low-Current Scans

    Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.

    Product
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1099-2013·2013-04-17

    US Endoscopy Recalls Torrent Irrigation Tubing Due to Water Leakage

    US Endoscopy Group Inc is recalling Torrent irrigation tubing because customers reported water leakage from the white tubing connector.

    Product
    Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2013·2013-04-17

    Ormco Recalls Bracket Buccal Tubes Due to Packaging Error

    Ormco is voluntarily recalling one lot of Bracket Buccal Tubes because the packaging incorrectly identifies the product offset, which may cause unintended tooth rotation.

    Product
    Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2013·2013-04-17

    Toshiba MRI Systems Recalled for LCD Monitor Backlight Failure

    Toshiba American Medical Systems is recalling 27 Titan X and Titan 3T MRI systems because the console LCD monitor backlight may turn off during use.

    Product
    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1086-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 635 Type I First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

    Product
    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-245-2013·2013-04-17

    Teva Recalls Portia Tablets Due to Appearance Specification Failures

    Teva Pharmaceuticals is recalling Portia (levonorgestrel and ethinyl estradiol) tablets because they failed appearance specifications.

    Product
    PORTIA — PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1075-2013·2013-04-17

    Tosoh G7 HPLC Analyzer Recalled for Beta-Thalassemia Detection Failure

    Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.

    Product
    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1090-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 41,595 First Aid Type III kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.

    Product
    LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1091-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 227 First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.

    Product
    LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1089-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 1,034 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.

    Product
    LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1088-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling

    Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits because the iodine ampule labels incorrectly imply the entire package is sterile.

    Product
    LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1304-2013·2013-04-17

    Ferrous Sulfate Tablets Recalled for Foreign Material Contamination

    Magno Humphries Inc is recalling Ferrous Sulfate Tablets 325 mg due to the presence of minute pieces of blue polypropylene plastic.

    Product
    Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part "OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculat
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-246-2013·2013-04-17

    Teva Recalls Jolessa Tablets Due to Appearance Specification Failures

    Teva Pharmaceuticals is recalling specific lots of Jolessa tablets because they failed appearance specifications. The recall is nationwide.

    Product
    JOLESSA — JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1087-2013·2013-04-17

    Lighthouse For The Blind Recalls Antiseptic Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling 2,815 antiseptic kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.

    Product
    LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1092-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits Due to Sterility Labeling Error

    Lighthouse For The Blind is recalling First Aid Type IV Belt Type kits because the iodine ampule labels incorrectly imply the entire package is sterile.

    Product
    LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1093-2013·2013-04-17

    Lighthouse For The Blind Recalls First Aid Kits With Misleading Sterility Labels

    Lighthouse For The Blind is recalling 425 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.

    Product
    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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