The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
63
Severe
381
High
255
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 47% are Severe.

601–700 of 807

  • SevereFDA (Devices)·Z-2752-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 62 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0069-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.

    Product
    LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2635-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 206 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070", REF SA6MAC30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0061-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.

    Product
    Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2740-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 17 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0077-2020·2019-10-09

    KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is nationwide.

    Product
    NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0032-2020·2019-10-09

    Colonia Care Pharmacy Recalls Tacrolimus Ophthalmic Suspension Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product cannot be guaranteed.

    Product
    C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0057-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0037-2020·2019-10-09

    Quality Electrodynamics Recalls Siemens Knee and Extremity MRI Coils

    Quality Electrodynamics LLC is recalling 21 Siemens MRI coils due to potential ferrous material in the pushbutton assembly.

    Product
    TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2580-2019·2019-10-09

    Medtronic Recalls 9 Units of Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2728-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2667-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2602-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 172 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2699-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 6 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2734-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 330 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2636-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 61 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0059-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2572-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 221 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2707-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling 26 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2625-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 152 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2628-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3,058 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0122-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0097-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2020·2019-10-09

    KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.

    Product
    NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0026-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0101-2020·2019-10-09

    Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.

    Product
    Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2020·2019-10-09

    KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling ephedrine sulfate syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2577-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2585-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 42 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2645-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 248 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2671-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 191 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070", REF SA6SAL10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2571-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 1,701 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2662-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 102 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070", REF SA6JR30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1883-2019·2019-10-09

    Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.

    Product
    Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a lack of assurance of sterility.

    Product
    C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0111-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2750-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 80 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2599-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 20 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2687-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2705-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 27 units of the Sherpa NX Active Guiding Catheter because the primary segment material may break, exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0092-2020·2019-10-09

    KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns

    KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.

    Product
    Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0096-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.

    Product
    Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution because the product's sterility cannot be guaranteed.

    Product
    C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2615-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 6F Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0084-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection

    KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2652-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 237 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2694-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 48 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2583-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 555 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0098-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2624-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3,302 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2683-2019·2019-10-09

    Medtronic Recalls 14 Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0104-2020·2019-10-09

    FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.

    Product
    SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2747-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of the SHERPA NX ACTIVE GUIDING CATHETER because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0016-2020·2019-10-09

    Valencia Fry Bread Mix Recalled for Undeclared Milk

    Valencia Flour Mill, Ltd. is recalling Valencia Fry Bread Mix because it contains undeclared milk. The product was distributed in New Mexico.

    Product
    Valencia Fry Bread Mix, 2 lbs., packaged in Paper bags with polyliners. UPC 7 30701 33002 4
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0004-2020·2019-10-09

    Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking

    The Metrix Company is recalling 14,1120 Secure EVA dual chamber IV bags due to a potential for leaking. The affected products were distributed in the US and Canada.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2257-2019·2019-10-09

    Whole Flower Farms Recalls Chocolate Chip Cookies for Undeclared Soy

    Whole Flower Farms LLC is recalling 27 units of Chocolate Chip Cookies due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Chocolate Chip Cookie*** Ingredients: Sunflower oil, brown sugar, almond milk, evaporated cane juice…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0019-2020·2019-10-09

    Paltop Advanced Plus Dental Implant Recall for Surface Topography Defects

    Paltop Advanced Dental Solutions is recalling 167 dental implants because surface micro/nano topography may be inconsistent. The recall covers units distributed to 16 states.

    Product
    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Drugs)·D-0056-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 159 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V717000·2019-10-09

    2020 Thomas Built Buses Minotour Recalled for Seatbelt Warning Light Defect

    Daimler Trucks North America is recalling 2020 Thomas Built Buses Minotour school buses because the seatbelt-unfastened warning light may not illuminate for five seconds after ignition.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2020·2019-10-09

    Stryker C2 Nerve Monitor Recalled for Potential Nerve Injury Risk

    Stryker is recalling 135 C2 Nerve Monitor units because design and instruction issues may lead to use errors that cause nerve injury.

    Product
    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2020·2019-10-09

    Stryker Recalls C2 Nerve Monitor Due to Usability Design Issues

    Stryker is recalling 135 C2 Nerve Monitor units because design and instruction usability issues may lead to use errors and potential nerve injury.

    Product
    C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2256-2019·2019-10-09

    Whole Flower Farms Peanut Butter Chocolate Chip Cookies Recalled for Undeclared Soy

    Whole Flower Farms LLC is recalling Peanut Butter Chocolate Chip Cookies due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Peanut Butter Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Peanut Butter Chocolate Chip Cookie*** Ingredients: Peanut Butter, evaporated cane juice…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0110-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.

    Product
    Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 153 units of Triathlon Femoral Distal Augments because a device overhang issue causes them to protrude beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2020·2019-10-09

    Voco Grandio SO Heavy Flow Caps Recalled for Loose Cannula

    Voco GmbH is recalling Grandio SO Heavy Flow Caps because the metal cannula may be too loose and detach during use.

    Product
    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2757-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0018-2020·2019-10-09

    Peanut Butter Cookies Recalled for Undeclared Peanut Allergen

    Southeastern Grocers is recalling 18-count Peanut Butter Cookies because the ingredient labels failed to declare peanuts.

    Product
    SE Grocers **BAKERY** 18 CT Peanut Butter Cookies
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0003-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Acetylcysteine Ophthalmic 10% Solution because the sterility of the product cannot be guaranteed.

    Product
    C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0033-2020·2019-10-09

    Quality Electrodynamics Recalls MRI Extremity Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling five Siemens MRI extremity coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2259-2019·2019-10-09

    Whole Flower Farms Recalls Oatmeal Chocolate Chip Cookies for Undeclared Soy

    Whole Flower Farms LLC is recalling Oatmeal Chocolate Chip Cookies due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Oatmeal Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Oatmeal Chocolate Chip Cookie***Ingredients: Brown sugar, sunflower oil, almond milk, flax…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2767-2019·2019-10-09

    WOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error

    WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.

    Product
    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2020·2019-10-09

    Baxter Integrated APD Set Recalled for Potential Cassette Leaks

    Baxter Healthcare is recalling L5C4531 X1 Integrated APD Sets because cassettes may leak, risking sterile fluid path contamination and peritonitis.

    Product
    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-0063-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 30 mg/30 mL for IM use due to a lack of assurance of sterility.

    Product
    Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0015-2020·2019-10-09

    Valencia Sopaipilla Mix Recalled for Undeclared Milk Allergen

    Valencia Flour Mill, Ltd. is recalling Sopaipilla Mix because it contains undeclared milk. The product was distributed in New Mexico.

    Product
    Valencia Sopaipilla Mix, 5 lbs. and 2 lbs., packaged in Paper bags with polyliners. UPC 7 30701 22005 5. And 2 lb UPC 7 30701 22002 4
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0015-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Interferon Alfa2B Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Interferon Alfa2B ophthalmic solution because the product's sterility cannot be guaranteed.

    Product
    C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0014-2020·2019-10-09

    Valencia Flour Mill Recalls Sopaipilla Mix for Undeclared Milk

    Valencia Flour Mill is recalling Sopaipilla and Fry Bread Mix because it contains undeclared milk, a major food allergen.

    Product
    Valencia Sopaipilla and Fry Bread Mix, 25 lbs, packaged in Paper bags with polyliners. UPC 7 30701 22025 3
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0008-2020·2019-10-09

    Baxter ExactaMix IV Bags Recalled for Potential Leaking

    The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.

    Product
    ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2260-2019·2019-10-09

    Whole Flower Farms Peppermint Brownie Recalled for Undeclared Soy Lecithin

    Whole Flower Farms LLC is recalling 30 units of Peppermint Brownie due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Peppermint Brownie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Peppermint Brownie*** Ingredients: Evaporated cane juice, sunflower oil, almond milk, cocoa powder, chocolate…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0035-2020·2019-10-09

    Quality Electrodynamics Recalls 15CH Knee Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling five Siemens 15CH Knee Coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0006-2020·2019-10-09

    Metrix Secure EVA IV Bags Recalled for Potential Leaking

    The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed in the US and Canada.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2020·2019-10-09

    FDA Recalls ExactaMix IV Bags Due to Potential Leaking

    The FDA is recalling 175,392 ExactaMix IV bags due to a potential for leaking. The bags are used for intravenous admixture programs.

    Product
    ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2019·2019-10-09

    Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Export

    Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative results.

    Product
    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0003-2020·2019-10-09

    Metrix Secure EVA IV Bags Recalled for Potential Leaking

    The Metrix Company is recalling 1,512 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide in the US.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2020·2019-10-09

    Metrix Secure EVA Dual Chamber Container Recall for Leaking

    The Metrix Company is recalling 4,284 Secure EVA dual chamber containers due to a potential for leaking. The affected bags are used for intravenous admixtures.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2020·2019-10-09

    KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2020·2019-10-09

    Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking

    The Metrix Company is recalling 234,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed nationwide in the US.

    Product
    SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2020·2019-10-09

    Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0062-2020·2019-10-09

    KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

    Product
    Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0010-2020·2019-10-09

    Gold Medal Flour Recalled for Potential E. coli O26:H11 Contamination

    General Mills is recalling 5 lb bags of Gold Medal Unbleached All Purpose Flour due to potential E. coli O26:H11 contamination.

    Product
    Gold Medal Enriched, Presifted, Unbleached All Purpose Flour, Net Wt. 5 lb (2.26 kg), in paper bags. UPC 16000-19610
    Category
    Food
    Distribution
    28 states

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