États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
CPSCPrismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries and Statute for Battery Packaging
Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries and Statute for Battery Packaging
The recalled book nooks violate the mandatory standard for consumer products containing button cell or coin batteries because the nooks include a spare lithium coin battery that can be easily accessed by children. In addition, the spare coin battery is not in child resistant packaging, and the packaging does not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
CPSCMeijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's Sleepwear
Meijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's Sleepwear
The recalled sleepwear violates the mandatory flammability standard for children's sleepwear, posing a risk of burn injuries to children.
FDA DevicesSurepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Drugsvancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Lack of Assurance of Sterility
FDA DrugsTestosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesAzurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA DrugsESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsTestosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesSpectral CT 7500 on Rails; Product Code (REF): 728334;
Spectral CT 7500 on Rails; Product Code (REF): 728334;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
FDA DrugsCetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Defective Delivery System: Missing or duplicated needles within the injection kit
FDA DevicesAzurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA FoodCREAMY PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY US FOODS, ROSEMONT, IL 60018; PEANUT BUTTER NET WT. 0.5OZ & NET WT 0.75OZ DIST BY: DYMA BRANDS, INC. ATLANTA, GA 30328; Product also sold under the following brand names: FLAVOR Fresh PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY: DYMA BRANDS, INC. ATLANTA, GA 30328; HOUSE RECIPE CREAMY PEANUT BUTTER NET WT 0.75 OZ (21.2g) DISTRIBUTED BY SYSCO COROPRATION, HOUSTON, TEXAS 77077; Katy's Kitchen SMOOTH PEANUT BUTTER NET WT 0.75 OZ (21g) MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTIN, TX 77043 PEANUT BUTTER creamy NET WT 0.75 OZ (21g) FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE WYOMING, MI 49509; CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
CREAMY PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY US FOODS, ROSEMONT, IL 60018; PEANUT BUTTER NET WT. 0.5OZ & NET WT 0.75OZ DIST BY: DYMA BRANDS, INC. ATLANTA, GA 30328; Product also sold under the following brand names: FLAVOR Fresh PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY: DYMA BRANDS, INC. ATLANTA, GA 30328; HOUSE RECIPE CREAMY PEANUT BUTTER NET WT 0.75 OZ (21.2g) DISTRIBUTED BY SYSCO COROPRATION, HOUSTON, TEXAS 77077; Katy's Kitchen SMOOTH PEANUT BUTTER NET WT 0.75 OZ (21g) MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTIN, TX 77043 PEANUT BUTTER creamy NET WT 0.75 OZ (21g) FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE WYOMING, MI 49509; CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328
Foreign material. During production, the firm found pieces of blue plastic in a filter.
FDA DrugsTestosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA Drugsacyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
Lack of Assurance of Sterility
FDA DrugsESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesMedline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DevicesReprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA DrugsTestosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesSurepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA DrugsTestosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsTestosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodCarrot Top Kitchens Lime Ginger Hummus; contains chickpeas, tahini, fresh ginger, lime juice & zest, salt; 8 oz.
Carrot Top Kitchens Lime Ginger Hummus; contains chickpeas, tahini, fresh ginger, lime juice & zest, salt; 8 oz.
Contains undeclared sesame