Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA DevicesCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesPhilips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA Devicesi-STAT EG6+ cartridge; List Number: 03P77-25;
i-STAT EG6+ cartridge; List Number: 03P77-25;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA Food52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7
52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
FDA DevicesBrand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Due to complaints of device breakage at the traction force gauge to handle joint.
FDA DevicesCenturion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DrugsiVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA FoodMy Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
Foreign object found inside retail container.
FDA DevicesHeraeus, PALAMIX uno. Material Number: 66057893.
Heraeus, PALAMIX uno. Material Number: 66057893.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesHeraeus, PALAMIX duo. Material Number: 66057897.
Heraeus, PALAMIX duo. Material Number: 66057897.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
FDA DrugsSimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA DevicesDimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
FDA FoodNegita Cracker- Shrimp 2.8oz
Negita Cracker- Shrimp 2.8oz
Contains undeclared FD&C Yellow 6
FDA Food52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA FoodTop Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228.
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228.
Undeclared allergen (almond).
FDA DevicesPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA Devicesi-STAT EG7+ cartridge; List Number: 03P76-25;
i-STAT EG7+ cartridge; List Number: 03P76-25;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA DevicesBrand Name: Leksell Vantage Arc System REF: 1053958
Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
FDA DrugsfentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
cGMP deviations.