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High RiskFDA
Icu Medical, Inc.
TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable...
Surgical Devices·2,640 affected·Sep 27, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 a...
Diagnostic Devices·139 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transdu...
Surgical Devices·660 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Trans...
Surgical Devices·275 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·160 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable S...
Surgical Devices·710 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...
Surgical Devices·280 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Ite...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer t...
Cardiac Devices·80 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), It...
Surgical Devices·730 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable...
Surgical Devices·520 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight P...
Surgical Devices·105 affected·Sep 27, 2016
High RiskFDA
Ssi-gopicnic Llc
GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Packed Snacks; GLUTEN FREE; Best by: 31 JAN 2017
Dairy·1,584 affected·Sep 26, 2016
High RiskFDA
Hamilton Medical, Inc.
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and p...
Respiratory Devices·44 affected·Sep 26, 2016
High RiskFDA
R.w.garcia Co., Inc.
RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R....
Bakery & Grains·200 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
365, Lightly Salted Tortilla Chips, Multigrain, Net Wt. 16oz. (1 lb.) 454g, Distributed by Whole Foods Market, Austin, TX 78703.
Snacks & Candy·143 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Sesame & Chia), Gluten Free, Net Wt., 30 oz., Product of USA, Manufactured & Distrib...
Bakery & Grains·9,760 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Veg...
Bakery & Grains·49 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
Harris Teeter, Multigrain, Tortilla Chips, Net Wt. 12 oz. (340g), Produced by Harris Teeter, Mathews, NC 28105.
Snacks & Candy·72 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
365, White Corn, Tortilla Chips, Unsalted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.
Snacks & Candy·425 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Black & White sesame Seeds), Gluten Free, Net Wt., 180g and 850g, Product of USA, Ma...
Bakery & Grains·4,700 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
Central Market, Tortilla Chips, Veggie & Seed Blend, Net Wt.; 12oz (340g), Distributed by H.E.B Central Markets, Austin, TX 78735.
Snacks & Candy·848 affected·Sep 25, 2016
High RiskFDA
R.w.garcia Co., Inc.
Trader Joes, Veggie Flaxseed Tortilla Chips, Net Wt. 12oz. (340g), Distributed and Sold by Trader Joes, Monrovia, CA 91014.
Snacks & Candy·3,228 affected·Sep 25, 2016
High RiskFDA
Batista Bakery & Pastries, Inc.
Baptista Bakery & Pastry Inc. Italian Bread, 16 oz. plastic
Bakery & Grains·30 affected·Sep 23, 2016
High RiskFDA
Batista Bakery & Pastries, Inc.
Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plastic
Bakery & Grains·30 affected·Sep 23, 2016
High RiskFDA
Truco Enterprises, Inc
On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows.
Snacks & Candy·48,808 affected·Sep 23, 2016
High RiskFDA
Batista Bakery & Pastries, Inc.
Baptista Bakery & Pastry Inc. Bulkie Rolls, 16 oz. plastic
Bakery & Grains·30 affected·Sep 23, 2016
High RiskFDA
Mericon Industries Inc.
Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02
Supplements·158 affected·Sep 23, 2016
High RiskFDA
Truco Enterprises, Inc
On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.
Snacks & Candy·11,753 affected·Sep 23, 2016
High RiskFDA
Batista Bakery & Pastries, Inc.
Baptista Bakery & Pastry Inc. Portugese Sliced Bread, 16 oz. plastic
Bakery & Grains·30 affected·Sep 23, 2016
High RiskFDA
Sequent Medical Inc
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interve...
Medical Implants·618 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Medical Devices·130 affected·Sep 23, 2016
High RiskFDA
Cardinal Health 200, Llc
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Medical Devices·72,076 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Manifold Kit. Catalog Number K09-11867AP
Medical Devices·40 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Medical Devices·53 affected·Sep 23, 2016
High RiskFDA
Azteca Milling Lp
Tortilla Chip 2 White Corn Masa Flour 50 lb bags
Snacks & Candy·37,500 affected·Sep 22, 2016
High RiskFDA
Dollar General Corporation
Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland
Bakery & Grains·146,455 affected·Sep 22, 2016
High RiskFDA
Azteca Milling Lp
Taco 4 Blue Corn Masa Flour 50 lb bags
Food·46,350 affected·Sep 22, 2016
High RiskFDA
Azteca Milling Lp
Taco 6 White NGMO Corn Masa Flour 50 lb bags
Food·30,100 affected·Sep 22, 2016
High RiskFDA
Azteca Milling Lp
Truco 1 50/50 Corn Masa Flour 50 lb bags & totes
Food·491,875 affected·Sep 22, 2016
High RiskFDA
Azteca Milling Lp
Tortilla Chip #8 Especial White NGMO Corn Masa Flour 50 lb bags
Snacks & Candy·243,708 affected·Sep 22, 2016
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging ...
Surgical Devices·14 affected·Sep 22, 2016
High RiskFDA
Atricure, Inc.
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 7...
Cardiac Devices·5,263 affected·Sep 22, 2016
High RiskFDA
Waymouth Farms, Inc
Good Sense Trail Mix, Cranberries 'N More, Net Wt. 6 oz. (170g). Cranberries, Sunflower Nuts, Cashews, Pumpkin Seeds, Almonds, Apples. ...
Produce·2,640 affected·Sep 21, 2016