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FDA DevicesMedline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA FoodYoyo Gummy Tropical Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Tropical Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA DevicesBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Knee and Humeral socket implants contain incorrect labeling.
FDA DevicesOlympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Fidget Spinner LED Light Up Pen
The toy doesn’t comply with the mandatory standards for products containing button/coin batteries . The battery isn’t secured, and children could access the button/coin battery. The product is missing warning information about: the dangers of button/coin batteries to children what to do when a person suspects someone has swallowed or placed a button/coin battery inside any part of their body
Travel Hairdryer XDM 3600
The hairdryer’s motor may overheat, causing the folding switch to fail and the plastic grill to ignite.
FDA FoodTiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
Ingredients List declares peanut but the Contains statement does not declare peanut
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesCampy CVA Medium 100/PK, R01272
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
FDA FoodYO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
Product contains undeclared cyclamates.
NHTSAVolkswagen Group of America, Inc. - Lane Departure Warning Deactivated
Volkswagen Group of America, Inc. - Lane Departure Warning Deactivated
The driver may be unaware that the lane departure warning system is deactivated and rely on a system that is not functional, increasing the risk of a crash.
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DrugsBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DevicesOlympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
FDA DrugsEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
FDA DevicesPIE Trolley System Model: 2005
PIE Trolley System Model: 2005
Lack of 510K clearance
FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DrugsVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DevicesMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA FoodYoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA FoodYoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA DevicesOlympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Health CanadaImportation of US-Authorized Vasopressin Injection, USP, 20 units/mL (For IV Infusion) Due to the Current Shortage of Canadian-Authorized Vasopressin Injection, USP, 20 units/mL (For IM or SC Administration)
Importation of US-Authorized Vasopressin Injection, USP, 20 units/mL (For IV Infusion) Due to the Current Shortage of Canadian-Authorized Vasopressin Injection, USP, 20 units/mL (For IM or SC Administration)
Product safety - Packaging - Supply
Health CanadaTransport Canada Recall - 2025628 - FORD
Transport Canada Recall - 2025628 - FORD
High Voltage