The Recall Desk

Archive

May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical
45
Severe
174
High
254
Moderate
259
Low
39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

1–100 of 771

  • CriticalFDA (Food)·F-2246-2017·2017-05-31

    Chef Luca's Frozen Lasagna Recalled for Undeclared Eggs

    Italian Gluten Free Foods CL is recalling Chef Luca's Lasagna Al Forno due to undeclared eggs. The product was distributed in nine states.

    Product
    Chef Luca's Italian Gluten Free Foods Lasagna Al Forno Baked Cheese Lasagna, 15 oz . frozen UPC Code: 85573103116
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2268-2017·2017-05-31

    Tropic Fish Hawaii Recalls Frozen Yellowfin Tuna Cubes for Hepatitis A

    Tropic Fish Hawaii is recalling 150 cases of Reel Fresh Yellowfin Tuna Hilo Cubes because the product tested positive for hepatitis A. The affected tuna was distributed on the Island of Oahu.

    Product
    Yellowfin Tuna Hilo Cubes, Random cut. 15 lb. cases. (1 x 15 lb. bags per case) Brand name: Reel Fresh UPC: 664183001454 Ingredients: Frozen tuna and carbon monoxide (to promote color retention). Product of Indonesia, Wild Caught
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2269-2017·2017-05-31

    Nutty INFUSIONS Ginger Wasabi Cashew Butter Recalled for Listeria Contamination

    Huson Valley Farms is recalling Nutty INFUSIONS Ginger Wasabi Cashew Butter due to Listeria monocytogenes contamination. The product was distributed nationwide through a wholesale in Illinois.

    Product
    Nutty INFUSIONS Ginger Wasabi Cashew Butter, NET WT. 10 OZ (284 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2266-2017·2017-05-31

    Huson Valley Farms Recalls Cashew Butter for Listeria Contamination

    Huson Valley Farms is recalling 5,022 jars of Nutty INFUSIONS Roasted Cashew Butter due to Listeria monocytogenes contamination. The product was distributed nationwide through a wholesale in Illinois.

    Product
    Nutty INFUSIONS Roasted Cashew Butter, NET WT. 10 OZ (284 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0862-2017·2017-05-31

    Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate

    Hospira is recalling 71,550 syringes of Infant 25% Dextrose Injection because human hair was found in an internal sample. The product was distributed nationwide and in Puerto Rico.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0864-2017·2017-05-31

    Hyland's Baby Nighttime Teething Tablets Recalled for Inconsistent Belladonna Alkaloids

    Standard Homeopathic Company is recalling Hyland's Baby Nighttime Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids.

    Product
    Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottl
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2245-2017·2017-05-31

    Phoenix Food Recalls Dip Trio Mix for Possible Salmonella Contamination

    Phoenix Food, LLC is recalling 11,936 boxes of Dip Trio Mix due to possible Salmonella contamination. The product was distributed across 25 U.S. states and Canada.

    Product
    Dip Trio Mix Homemade Gourmet Dip Mix Net Wt. 2.9 oz. Distributed by: Phoenix Food, LLC. Canton, TX 75103 www.homemadegourmet.com
    Category
    Food
    Distribution
    24 states
  • CriticalFDA (Drugs)·D-0867-2017·2017-05-31

    Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine

    Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.

    Product
    LaBri's Body Health Atomic, 60 capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2241-2017·2017-05-31

    Starbucks Slow Roasted Ham & Swiss Sandwich Recalled for Listeria

    SK Food Group is recalling Starbucks Slow Roasted Ham & Swiss Breakfast Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Slow Roasted Ham & Swiss Breakfast Sandwich, Fully Cooked/Keep Frozen/Perishable Net Wt 5.6 oz (159 g) MANUFACTURED EXCLUSIVELY FOR STARBUCKS COFFEE COMPANY SEATTLE, WA 98134 UPC 7 62111 10495 1
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0863-2017·2017-05-31

    Hyland's Baby Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels

    Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from label claims.

    Product
    Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bo
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V351000·2017-05-31

    Spartan Recalls 2010-2014 Chassis Due to Starter Motor Fire Risk

    Spartan Motors is recalling 2010-2014 K2, K3, and Gladiator chassis because a starter motor component may break, causing overheating and increasing fire risk.

    Product
    SPARTAN — SPARTAN GLADIATOR, K3, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0854-2017·2017-05-31

    Sato Pharmaceutical Recalls Optic Splash Eye Drops Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·17V349000·2017-05-31

    Pierce Fire Trucks Recalled for Rear Sway Bar Detachment Risk

    Pierce Manufacturing is recalling 2012-2017 fire trucks because a rear sway bar may detach, increasing crash risk during steering.

    Product
    PIERCE — PIERCE ARROW XT, ENFORCER, QUANTUM, DASH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0855-2017·2017-05-31

    Sato Clear Eye Drops Recalled for Sterility Assurance Failure

    Sato Pharmaceutical is recalling Sato Clear eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0856-2017·2017-05-31

    Sato Pharmaceutical Recalls DORAMA-NEO Eye Wash Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO eye wash because the manufacturer failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2119-2017·2017-05-31

    EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity

    EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.

    Product
    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2244-2017·2017-05-31

    Rich Products Recalls Artisan Crust Pizza Dough Due to E. coli Risk

    Rich Products Corp is recalling Artisan Crust Pizza Dough because the flour used may be contaminated with E. coli O121.

    Product
    ARTISAN CRUST PIZZA DOUGH 24/18, PRODUCT CODE 11413, UPC 1 00 49800 11413 2, NET CASE WT: 27 LB (12.2 KG), UNIT NET WT: 18 OZ (1 LB 2 OZ) (510G), COUNT: 24 --- PROCESSED IN CANADA DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2142-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Wound Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt PVC Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque sect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2017·2017-05-31

    Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices

    Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.

    Product
    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2017·2017-05-31

    CORPAK CORFLO PEG Adaptor Repair Kit Recalled for Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break unexpectedly when exposed to stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syri
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2150-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2017·2017-05-31

    Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk

    Stryker is recalling Hoffmann LRF Safety Clips because they may loosen from the Quick Release mechanism on Transport Struts.

    Product
    Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2236-2017·2017-05-31

    Lords Organics Recalls Ginger Powder Due to Salmonella Contamination Risk

    Lords Organics is recalling Organic Veda brand Ginger Powder because it may be contaminated with Salmonella. The recall covers 96 units distributed nationwide.

    Product
    Organic Veda brand Ginger Powder, 24 jars, Net Wt. 16 oz. (454 grams)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2017·2017-05-31

    Merge Cardio software recalled for incorrect fetal measurement data retrieval

    Merge Healthcare is recalling Merge Cardio software versions 10.0 through 10.1.2 because the software may display incorrect fetal measurements by pulling data from prior pregnancies.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2145-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2242-2017·2017-05-31

    Rich Products Recalls Artisan-Style Pizza Dough Balls Due to E. coli Risk

    Rich Products Corp is recalling specific lots of Artisan-Style Pizza Dough Balls because they were made with flour potentially contaminated with E. coli O121.

    Product
    ARTISAN-STYLE PIZZA DOUGH BALL distributed under the following sizes and Product Codes: (a) 12 OZ ARTISAN-STYLE PIZZA DOUGH BALL, RICH'S label, Product Code 11268, UPC 0 00 49800 11268 1, NET CASE WT: 12.2 KG (27 LB), UNIT NET WT: 340 G (12G), COUNT: 36; (b) 18 OZ ARTISAN-STYLE
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2143-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2017·2017-05-31

    EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity

    EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.

    Product
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2017·2017-05-31

    Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

    Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2017·2017-05-31

    CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2146-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise

    Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2017·2017-05-31

    B. Braun Recalls CytoGuard Closed Luer Connectors Due to Sterility Concerns

    B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors because some blisters may be punctured, compromising the sterility barrier.

    Product
    CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2017·2017-05-31

    Teleflex Recalls Infant Catheter Connectors Due to Sterility Concerns

    Teleflex Medical is recalling 19,043 units of INFANT 20/BX sterile catheter connectors. The recall was initiated voluntarily due to a lack of reason for recall in the source text.

    Product
    INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2017·2017-05-31

    Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps

    Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2144-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaq
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2251-2017·2017-05-31

    U-Can Food Trading Recalls Sugar Crackers for Undeclared Soy

    U-Can Food Trading is recalling Sugar Crackers because they may contain undeclared soy. The recall affects 970 cartons distributed in four US states.

    Product
    Sugar Crackers 400g (14.1oz) x 12 packets per carton/case, UPC 9556184 500023
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2163-2017·2017-05-31

    CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under stress.

    Product
    CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceabl
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-2243-2017·2017-05-31

    Rich Products Recalls Pizza Dough Balls Due to E. coli 0121 Risk

    Rich Products Corp is recalling 7 oz pizza dough balls because the flour used may be contaminated with E. coli 0121.

    Product
    7 OZ PIZZA DOUGH BALL, PRODUCT CODE 11267, UPC 0 00 49800 1267 4, NET CASE WT 12.9 KG (28 LB 7 OZ), UNIT NET WT: 198 G (7 OZ), COUNT: 65 --- PROCESSED IN CANADA, DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2164-2017·2017-05-31

    Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures

    Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.

    Product
    SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0804-2017·2017-05-31

    Advanced Pharma Recalls Standard Starter TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling Standard Starter TPN products because they may contain synthetic or natural latex without proper labeling.

    Product
    Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0706-2017·2017-05-31

    Mylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures

    Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0794-2017·2017-05-31

    Advanced Pharma Recalls Bupivacaine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling Bupivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not properly labeled.

    Product
    Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2017·2017-05-31

    Advanced Pharma Recalls Cefazolin Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Cefazolin because the product may contain latex but lacks appropriate labeling.

    Product
    Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2017·2017-05-31

    Advanced Pharma Recalls Norepinephrine Bitartrate for Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Norepinephrine Bitartrate because the product may contain synthetic or natural latex, which is not currently disclosed on the label.

    Product
    Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2017·2017-05-31

    Magnesium Sulfate Recall for Potential Latex Content

    Advanced Pharma Inc. is recalling Magnesium Sulfate products due to potential latex content not clearly labeled.

    Product
    Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0796-2017·2017-05-31

    Advanced Pharma Recalls Lidocaine Products Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Lidocaine products because they may contain latex but lack appropriate labeling.

    Product
    Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2017·2017-05-31

    Teleflex Medical Recalls PE Connector 3/8 Straight 20/BX Due to Missing Expiration Date

    Teleflex Medical is recalling 19,043 units of PE Connector 3/8 Straight 20/BX because the expiration date is missing from the labeling, creating a risk that expired product may be used.

    Product
    PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2017·2017-05-31

    Advanced Pharma Recalls Famotidine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Famotidine HCl because the product may contain latex but lacks proper labeling.

    Product
    Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0836-2017·2017-05-31

    Advanced Pharma Recalls Labetalol HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling Labetalol HCl products because labels may not properly disclose the presence of synthetic or natural latex.

    Product
    Labetalol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2017·2017-05-31

    Advanced Pharma Recalls Diltiazem HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Diltiazem HCl products because they may contain latex but lack proper labeling.

    Product
    Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0820-2017·2017-05-31

    Advanced Pharma Recalls Gentamicin Sulfate for Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Gentamicin Sulfate products due to a labeling error regarding potential latex content.

    Product
    Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0865-2017·2017-05-31

    Cell Distributors Recalls Refresh Tears Eye Drops for Labeling Defects

    Cell Distributors is recalling Refresh Tears eye drops because the product labels lack an NDC number, net weight, and Drug Facts Panel.

    Product
    Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2017·2017-05-31

    Teleflex Medical Recalls PE Connector 5 In 1 Due to Missing Expiration Date

    Teleflex Medical is recalling 19,043 units of PE Connector 5 In 1 catheter accessories because the expiration date is missing from the labeling, creating a risk that expired product may be used.

    Product
    PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0828-2017·2017-05-31

    Advanced Pharma Recalls Epinephrine HCl Products Due to Latex Labeling

    Advanced Pharma Inc. is recalling all Epinephrine HCl products because they may contain latex but lack appropriate labeling.

    Product
    Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl Citrate with Ropivacaine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling Fentanyl Citrate with Ropivacaine HCl because the product may contain latex and lacks appropriate labeling.

    Product
    Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2017·2017-05-31

    Advanced Pharma Recalls Calcium Gluconate for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling Calcium Gluconate products because they may contain latex without proper labeling.

    Product
    Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2017·2017-05-31

    Advanced Pharma Recalls 0.9% Sodium Chloride Slip Tip for Latex Labeling

    Advanced Pharma Inc. is recalling 0.9% Sodium Chloride Slip Tip products because they may contain latex without proper labeling.

    Product
    0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2017·2017-05-31

    Advanced Pharma Recalls Potassium Phosphate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Potassium Phosphate because the product may contain latex but lacks proper labeling.

    Product
    Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0845-2017·2017-05-31

    Advanced Pharma Recalls Dexamethasone Sodium Phosphate for Latex Labeling

    Advanced Pharma Inc. is recalling Dexamethasone Sodium Phosphate because the product may contain latex but lacks proper labeling.

    Product
    Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0821-2017·2017-05-31

    Advanced Pharma Recalls Oxytocin Due to Potential Latex Content

    Advanced Pharma Inc. is recalling all Oxytocin products due to a labeling issue regarding potential synthetic or natural latex content.

    Product
    Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0816-2017·2017-05-31

    Advanced Pharma Recalls Methohexital Sodium Due to Latex Labeling

    Advanced Pharma Inc. is recalling Methohexital Sodium because the product may contain latex but lacks proper labeling.

    Product
    Methohexital Sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0811-2017·2017-05-31

    Advanced Pharma Recalls Meperidine HCl for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Meperidine HCl because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl and Bupivacaine Products for Latex Labeling

    Advanced Pharma Inc. is recalling Fentanyl Citrate and Bupivacaine HCl products because labeling may not disclose the presence of synthetic or natural latex.

    Product
    Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0833-2017·2017-05-31

    Advanced Pharma Recalls Nitroglycerin Due to Latex Labeling Error

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Nitroglycerin because the product labeling may not correctly disclose the presence of synthetic or natural latex.

    Product
    Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2017·2017-05-31

    Advanced Pharma Recalls Sodium Citrate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Sodium Citrate because the product may contain latex without proper labeling.

    Product
    Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0814-2017·2017-05-31

    Advanced Pharma Recalls Midazolam HCl for Potential Latex Content

    Advanced Pharma Inc. is recalling all lots of Midazolam HCl because the product may contain synthetic or natural latex.

    Product
    Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2017·2017-05-31

    Beckman Coulter Recalls Microalbumin Reagent Due to Potential Out-of-Range Recovery

    Beckman Coulter is recalling Microalbumin Reagent Lot M609458 because it may recover outside the lower limit of the published insert range for Urine Protein Control Level 1.

    Product
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0839-2017·2017-05-31

    Advanced Pharma Recalls Neostigmine Methylsulfate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Neostigmine Methylsulfate because the product may contain latex without proper labeling.

    Product
    Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0797-2017·2017-05-31

    Advanced Pharma Recalls Nalbuphine Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Nalbuphine because the product labeling fails to disclose that it may contain synthetic or natural latex.

    Product
    Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2017·2017-05-31

    Siemens AXIOM Sensis Diagnostic Computer Recalled for Dust-Related Failures

    Siemens Medical Solutions is recalling 4,095 AXIOM Sensis diagnostic computers because dust accumulation can cause system failures, potentially interrupting clinical treatments.

    Product
    AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0792-2017·2017-05-31

    Fagron Recalls Estrone Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2017·2017-05-31

    Advanced Pharma Recalls Ondansetron HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Ondansetron HCl because the product labeling may not adequately disclose the presence of synthetic or natural latex.

    Product
    Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0815-2017·2017-05-31

    Advanced Pharma Recalls Lorazepam HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Lorazepam HCl because the product may contain synthetic or natural latex, which is not currently labeled.

    Product
    Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2153-2017·2017-05-31

    Innovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving

    Innovasis, Inc. is recalling 21 Opteryx Variable Rescue Screws because they are engraved with an incorrect, larger size (16 instead of 14).

    Product
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2017·2017-05-31

    Advanced Pharma Recalls Cardioplegic Solution for Latex Labeling Defect

    Advanced Pharma Inc. is recalling Cardioplegic Solution Maintenance due to a labeling error regarding potential latex content.

    Product
    Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2017·2017-05-31

    Advanced Pharma Recalls Phenylephrine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Phenylephrine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0834-2017·2017-05-31

    Advanced Pharma Recalls Nicardipine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Nicardipine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0812-2017·2017-05-31

    Advanced Pharma Recalls Morphine Sulfate for Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Morphine Sulfate because the product labeling does not indicate that it may contain synthetic or natural latex.

    Product
    Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide

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