Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
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 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 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 FoodCrunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.
Crunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.
Undeclared allergen - milk. Product contains butter; cream is listed as a sub-ingredient of the butter, but milk is not declared in the ingredients or a contains statement.
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 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(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 Devices1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.
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 DrugsUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
FDA DevicesHalyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Tyvek bag seal issue which may compromise sterility of the kit.
FDA DrugsESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
FDA DrugsTestosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodKirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.
Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.
Undeclared hazelnut.
FDA DevicesAzurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; 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 FoodSonic Tots, item number SON00543. Frozen potato product is packaged in clear unlabeled poly bags (6/5 lb), Net Wt 30 lbs (13.61 kg)/ case. UPC 0 00 72714 00543 5. Manufactured By: McCain Foods USA Inc. Oakbrook Terrace, IL.
Sonic Tots, item number SON00543. Frozen potato product is packaged in clear unlabeled poly bags (6/5 lb), Net Wt 30 lbs (13.61 kg)/ case. UPC 0 00 72714 00543 5. Manufactured By: McCain Foods USA Inc. Oakbrook Terrace, IL.
Foreign material (small hard plastic fragments).
NHTSAToyota Motor Engineering & Manufacturing - Loss of Drive Power from Transmission Damage
Toyota Motor Engineering & Manufacturing - Loss of Drive Power from Transmission Damage
A damaged transmission can cause a loss of drive power, increasing the risk of a crash. In addition, a damaged transmission can leak transmission fluid, increasing the risk of a fire.
FDA DevicesSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Surepulse VS Cap Extra Large REF: SP-163-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 DevicesMedline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
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 DevicesMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA DrugsTestosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsTestosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsTestosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsTestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesMedline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
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.