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High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00002-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Becton Dickinson & Company
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, t...
Diagnostic Devices·0 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheter...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features f...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maxim...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit; Product Codes: ASK-04020-DH
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maxima...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Echogenic Introducer Needle; Product Code: AN-04318
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Clear Fenestrated Drape with Adhesive; Product Code: CD-00001
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BA...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Perc...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Liberty Snacks Honey Roasted CASHEWS Net Wt. 1.2 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 libertysnacks@gmail.com UP...
Snacks & Candy·156 affected·Apr 10, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Liberty Snacks NUTS ALMOND RAISIN Mix Net Wt. 1.6 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 libertysnacks@gmail.com U...
Snacks & Candy·52 affected·Apr 10, 2018
High RiskFDA
Riddhi Usa Inc.
All dietary supplements manufactured and distributed by Riddhi USA Inc.
Supplements·0 affected·Apr 10, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Liberty Snacks Natural PISTACHIOS Net Wt. 1 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 libertysnacks@gmail.com UPC 8-...
Snacks & Candy·208 affected·Apr 10, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Liberty Snacks Raw ALMONDS Net Wt. 1.3 oz (#g) DISTRIBUTED BY Liberty Candy & Nuts Inc. 347.945.0540 libertysnacks@gmail.com UPC 8-04879-...
Snacks & Candy·208 affected·Apr 10, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By Heinens, Warrensville Hts., OH 44128 UPC 0-36232-01871-1
Food·40 affected·Apr 10, 2018
High RiskFDA
Ohio Hickory Harvest Brand Products Inc.
Hickory Harvest Island Fruit Mix NET WT 9 oz (255g) Distributed by: Hickory Harvest Foods, Akron, OH 44319 UPC 0-36232-06052-9
Produce·200 affected·Apr 10, 2018
High RiskFDA
Pharmalucence, Inc.
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Ma...
Drugs·157 affected·Apr 10, 2018
High RiskFDA
Bard Brachytherapy, Inc.
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-...
Medical Implants·70 affected·Apr 10, 2018
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manuf...
Topical Drugs·9,016 affected·Apr 9, 2018
High RiskFDA
Biomerieux Sa
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family...
Diagnostic Devices·59 affected·Apr 9, 2018
High RiskFDA
Covidien Llc
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN ...
Medical Implants·5,547 affected·Apr 9, 2018
High RiskFDA
Rockwell Medical, Inc
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to b...
Medical Devices·139 affected·Apr 7, 2018
High RiskFDA
The J.m. Smucker Company, Inc.
HUNGRY JACK Original PANCAKE & WAFFLE MIX NET WT 32 OZ (2 LB) 907 g
Bakery & Grains·9,619 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Medical Devices·50 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Medical Devices·30 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Medical Devices·100 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Medical Devices·881 affected·Apr 6, 2018
High RiskFDA
Aroa Biosurgery, Ltd.
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
Medical Devices·881 affected·Apr 6, 2018