Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DevicesAllura Xper FD20/10; Model Number: 722029;
Allura Xper FD20/10; Model Number: 722029;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesSMV DSI, System, Tomography, Computed, Emission
SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA DevicesBrand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
FDA FoodTops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances - Strawberry. Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626322 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Tops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances - Strawberry. Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626322 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Unapproved color (carmoisine).
FDA DrugsClaritin, 20 Count, UPC: 655708016305
Claritin, 20 Count, UPC: 655708016305
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesAllura Xper FD10/10; Model Number: 722005;
Allura Xper FD10/10; Model Number: 722005;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesAllura Xper FD10/10; Model Number: 722027;
Allura Xper FD10/10; Model Number: 722027;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DrugsTESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
FDA DrugsSwan, White Clear Alcohol, 50%, 16oz, 12 count
Swan, White Clear Alcohol, 50%, 16oz, 12 count
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesAllura Xper FD20 Biplane; Model Number: 722008;
Allura Xper FD20 Biplane; Model Number: 722008;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesSMV DSX New Line, System, Tomography, Computed, Emission
SMV DSX New Line, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA DevicesAllura Xper FD20 OR Table; Model Number: 722023;
Allura Xper FD20 OR Table; Model Number: 722023;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA FoodHerbsForever- Hingwastika Churna ; Ayruvedic Herbal Supplement; 90 VEGE Capsules; 100 GMS UPC: 8 07814 00622 4
HerbsForever- Hingwastika Churna ; Ayruvedic Herbal Supplement; 90 VEGE Capsules; 100 GMS UPC: 8 07814 00622 4
Potential undeclared allergen ingredient (Wheat)
FDA DevicesAllura Xper FD10; Model Number: 722003;
Allura Xper FD10; Model Number: 722003;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
NHTSAVolkswagen Group of America, Inc. - Park Outside - High Voltage Battery May Catch Fire
Volkswagen Group of America, Inc. - Park Outside - High Voltage Battery May Catch Fire
A vehicle fire while parked or driving can increase the risk of injury.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA DrugsBenadryl, 25'S 2PK Box, UPC 815556020316
Benadryl, 25'S 2PK Box, UPC 815556020316
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
NHTSAAlexis Fire Equipment Company - Loss of Vehicle Control from Loose Axle Clamp Fasteners
Alexis Fire Equipment Company - Loss of Vehicle Control from Loose Axle Clamp Fasteners
A loss of vehicle control increases the risk of a crash.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA FoodUkrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Undeclared Soy. Label did not include soy, which was used in product.
FDA DevicesMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
FDA DevicesVANTAGE TITAN 3T Model MRT-3010/MEXL-3010
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
FDA DevicesCentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.