The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
422
High
235
Moderate
212
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 45% are Severe.

Which agencies issued them

201–300 of 944

  • SevereFDA (Drugs)·D-0430-2020·2019-11-27

    Altaire iSolutions Nano Tears Lubricant Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2020·2019-11-27

    Altaire Eye Ointment Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling iSolutions ActivEyes Nighttime Lubricant Eye Ointment due to a lack of assurance of sterility.

    Product
    iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2020·2019-11-27

    CVS Health Lubricant Eye Ointment Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2020·2019-11-27

    Altaire Recalls Equate Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricant Gel Drops because the product lacks assurance of sterility. The recall affects 50,904 units distributed nationwide.

    Product
    Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0294-2020·2019-11-27

    Mann's Nourish Breakfast Fiesta Scramble Recalled for Listeria Risk

    Mann Packing Company is recalling Mann's Nourish Breakfast Fiesta Scramble due to a positive test for Listeria monocytogenes in a related product.

    Product
    Mann's Nourish Breakfast Fiesta Scramble 4 x 9.5 oz. UPC:716519038853
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0489-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 951 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0307-2020·2019-11-27

    Russ Davis Wholesale Recalls Steamed Vegetables for Listeria Risk

    Russ Davis Wholesale is recalling steamed broccoli, cauliflower, and carrots with butter due to potential Listeria monocytogenes contamination.

    Product
    Broccoli, Cauliflower & Carrots with Butter - 18 oz, and Broccoli & Cauliflower with Butter - 16 oz; packaged with a small generic clear label on Q & E Steamer bag.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0256-2020·2019-11-27

    Mann Packing Recalls Cauliflower Florets Due to Listeria Contamination

    Mann Packing Company is recalling various cauliflower floret products due to a positive test for Listeria monocytogenes.

    Product
    HEB Cauliflower Florets 10 oz. UPC: 41220322787 Mann's Organic Cauliflower Florets: 10 oz. UPC: 716519059995 Mann's Family Favorites Cauliflower Florets 10 oz. UPC: 716519014031 Mann's Brand: 3 lbs. UPC: 10716519040037 - Food Service 3 lbs. UPC: 10716519040013…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0427-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

    Cook Inc. is recalling 791 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 100 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 230 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2020·2019-11-27

    Cook Inc. Recalls Guardia Access Nano Embryo Transfer Catheters

    Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.

    Product
    Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0425-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 165 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Packaging Seal Defect

    Cook Inc. is recalling 35 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0378-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 45,864 units distributed nationwide.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0387-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 238,968 units distributed nationwide.

    Product
    CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 95 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 405 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Packaging Seal Defect

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2020·2019-11-27

    AMD Medicom Level 2 Masks Recalled Due to Packaging Error

    AMD Medicom Inc. is recalling Level 2 masks that may have been packed in Level 3 boxes, creating a risk of using lower-protection masks.

    Product
    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0272-2020·2019-11-27

    Mann Packing Recalls Sweet Kale Salad Blend for Listeria

    Mann Packing Company is recalling Sweet Kale Salad Blend after CFIA reported positive results for Listeria monocytogenes. Consumers should discard the product.

    Product
    Marketside Cali Rice 6 x 12 oz. UPC: 681131221818 Cauli Rice - Mann 6 x 12 oz. UPC: 716519069031 6 x 12 oz. UPC: 716519067969 - Canada MNN Hungryroot: Food Kit: No UPC Cauliflower Rice 20 x 14 oz. HR Marketside: Cauli Rice 6 x 12 oz. UPC: 681131221818…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0475-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 585 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 80 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 85 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2020·2019-11-27

    Altaire Recalls OCuSOFT Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution because the company cannot guarantee the product is sterile.

    Product
    OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2020·2019-11-27

    Altaire Recalls Altachlore Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling 46,345 units of Altachlore Sodium Chloride Ophthalmic Ointment nationwide due to a lack of assurance of sterility.

    Product
    ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT — ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0503-2020·2019-11-27

    Washington Homeopathic Products Recalls Silicea 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 426 bottles of Silicea 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0248-2020·2019-11-27

    Del Monte Spicy Pomodoro Linguine Recalled for Listeria Risk

    Mann Packing Company is recalling Del Monte Better Break Spicy Pomodoro Linguine due to a Listeria monocytogenes alert. Consumers should check best-by dates and stop eating the product.

    Product
    Del Monte brand Better Break Spicy Pomodoro; Linguine with Tomato Chipotle Sauce. UPC 717524671004 7 oz. container 6 x 7 oz. per carton
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 98 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0257-2020·2019-11-27

    Mann Packing Recalls Green Beans for Listeria Contamination

    Mann Packing Company is recalling various brands of green beans due to a positive test for Listeria monocytogenes. Consumers should check their pantries for the affected products.

    Product
    Green Beans: 12 oz. UPC 11110016645 Kroger Organic 12 oz. UPC: 68820106258 Compliments - Canada HEB Brand: 12 oz. UPC: 41220176083 32 oz. UPC: 41220903191 Mann's Organic: 10 oz. UPC: 716519049996 Mann's Family Favorites 24 oz. UPC: 716519045158 - US and…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0419-2020·2019-11-27

    Cincinnati Sub-Zero Recalls CoolBlue Hyper-Hypothermia Systems for Tissue Damage Risk

    Cincinnati Sub-Zero is recalling 5,291 CoolBlue Hyper-Hypothermia Systems because extended use above 40°C may cause tissue damage. Warning labels have been updated.

    Product
    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and in the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2020·2019-11-27

    Cincinnati Sub-Zero Recalls Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling 3,726 Blanketrol II Hyper-Hypothermia Systems to add warnings about potential tissue damage from extended high temperatures.

    Product
    Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 25 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The products were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 1,125 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0373-2020·2019-11-27

    CVS Health Natural Tears Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Natural Tears Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 152,369 units distributed nationwide.

    Product
    CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2020·2019-11-27

    BD Posiflush Syringes Recalled Due to Experimental Product Mix-Up

    Becton Dickinson is recalling BD Posiflush syringes because a limited number of experimental units were mixed with standard products.

    Product
    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2020·2019-11-27

    Auris Health Recalls Monarch Aspirating Biopsy Needles Due to Breakage Reports

    Auris Health is recalling 158 Monarch Aspirating Biopsy Needles because of reports of needle breakage. The devices were distributed to 11 states.

    Product
    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0297-2020·2019-11-27

    Mann's Crave a Bowl Spicy Marinara Recalled for Listeria Risk

    Mann Packing Company is recalling Mann's Crave a Bowl Spicy Marinara due to a positive test for Listeria monocytogenes in a related salad product.

    Product
    Mann's Crave a Bowl Spicy Marinara 6 x 7 oz. UPC:716519040078 - Canada
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0441-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 425 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 740 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2020·2019-11-27

    Altaire Recalls Equate Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Eye Allergy Relief Drops because the company cannot ensure the product is sterile.

    Product
    Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2020·2019-11-27

    AMD Medicom Recalls Level 3 Masks Due to Packaging Error

    AMD Medicom is recalling Level 3 masks because Level 2 masks may have been packed in Level 3 boxes. The masks are visually indistinguishable, creating a risk of using lower protection.

    Product
    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-0418-2020·2019-11-27

    Altaire Recalls ActivEyes Sterile Altalube Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling ActivEyes Sterile Altalube Ointment because the company cannot guarantee the product is sterile. Consumers should stop using the product and return it to the pharmacy.

    Product
    ALTALUBE — ALTALUBE (MINERAL OIL AND PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0321-2020·2019-11-27

    Russ Davis Wholesale Recalls Steaming Vegetables for Listeria Risk

    Russ Davis Wholesale is recalling 5 lb bags of steaming vegetables for foodservice use due to potential Listeria monocytogenes contamination.

    Product
    Steaming Vegetables, 5 lbs, packaged with a small generic white label on a plastic bag for foodservice use.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0445-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2020·2019-11-27

    Applied Medical Recalls Epix Electrosurgical Probes Due to Tip Insulation Shifting

    Applied Medical Resources Corp is recalling Epix Electrosurgical Probes because the tip insulation may shift unintentionally. The recall affects 28 units in the US and 112 units internationally.

    Product
    Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 1,679 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2020·2019-11-27

    Teleflex Recalls Hem-O-Lok AutoEndo5 Clip Appliers Due to Jamming

    Teleflex Medical is recalling 4,099 Hem-O-Lok AutoEndo5 clip appliers because they may jam or misload, potentially causing clips to fall out or break during surgery.

    Product
    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2020·2019-11-27

    BD Posiflush Pre-Filled Normal Saline Syringes Recalled Due to Labeling Mix-up

    Becton Dickinson is recalling BD Posiflush Pre-Filled Normal Saline Syringes because a limited number of experimental units were mixed with standard stock.

    Product
    BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0383-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2020·2019-11-27

    Siemens SOMATOM go.Top CT Systems Recalled for Missing Dose Documentation

    Siemens is recalling 14 SOMATOM go.Top CT systems in seven states because they fail to document radiation dose or issue alerts during specific interventional procedures.

    Product
    SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0467-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 265 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 470 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0160-2020·2019-11-27

    Mical Seafood Recalls Tuna Loin Due to Scombroid Food Poisoning Complaints

    Mical Seafood is recalling specific lots of tuna loin due to customer complaints of scombroid food poisoning. The recall covers products with production dates from April to May 2019.

    Product
    Tuna Loin 5-8 lb AAA CO 30lb case Tuna Loin 3-5 lb AAA CO 30lb case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0483-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 60 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 250 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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