Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA FoodOrganic Moringa Powder; 15kg/bag (bulk); Product code: GJ96
Organic Moringa Powder; 15kg/bag (bulk); Product code: GJ96
Moringa Powder ingredient positive for salmonella
FDA DevicesMiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
FDA DevicesMEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS984556M; 6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
FDA DevicesP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
FDA DevicesMedline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
FDA DrugsRohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Lack of Assurance of Sterility
FDA DrugsGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Presence of Particulate Matter: Hair was found in product
FDA DrugsAmlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
FDA DevicesFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
FDA DevicesFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
FDA DrugsLevothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
Subpotent Drug
FDA DrugsLevothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Subpotent Drug
FDA DevicesHalyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
FDA DrugsLevothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
Subpotent Drug
FDA DevicesPenumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
FDA FoodFusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw .
Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw .
Undeclared Allergen (Fish)
FDA DevicesSafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
FDA DrugsRising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
FDA Food1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams
1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams
Contaminated with Salmonella
FDA DevicesMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
FDA FoodNAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744
NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744
Undeclared sodium tripolyphosphate (STTP)
FDA DevicesHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
FDA DevicesMEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
FDA DevicesMedline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.