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High RiskFDA
Advanced Pharma Inc.
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 7705...
Drugs·0 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulm...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Medical Devices·50 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
Medical Devices·24 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Medical Devices·630 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
Medical Devices·24 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
Medical Devices·44 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
Medical Devices·46 affected·Jun 22, 2017
High RiskFDA
Quidel Corporation
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in...
Diagnostic Devices·1,078 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
Medical Devices·48 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fi...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Medical Devices·48 affected·Jun 22, 2017
High RiskFDA
Medtronic Perfusion Systems
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia can...
Medical Devices·63,053 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
Medical Devices·440 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Cardiac Devices·90 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
Medical Devices·597 affected·Jun 22, 2017
High RiskFDA
Neurologica Corporation
The GC80 Digital X-ray Imaging System
Medical Devices·45 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
Medical Devices·444 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Cardiac Devices·8 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
Medical Devices·120 affected·Jun 22, 2017
High RiskFDA
Texas Plum Line
Wild Plum Apricot Bread 16 oz packaged in a glass jar
Bakery & Grains·708 affected·Jun 21, 2017
High RiskFDA
Texas Plum Line
A Texas Praline 14 oz. wrapped in cellophane
Food·265 affected·Jun 21, 2017
High RiskFDA
Texas Plum Line
Special Dark Chocolate Cake 16 oz packaged in a glass jar
Bakery & Grains·156 affected·Jun 21, 2017
High RiskFDA
Texas Plum Line
A Creamy Praline 2 oz. wrapped in cellophane
Food·1,670 affected·Jun 21, 2017
High RiskFDA
Texas Plum Line
Sugar Plum Cake 16 oz packaged in a glass jar
Bakery & Grains·169 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceutica...
Drugs·660 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceut...
Drugs·20 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceutica...
Drugs·20 affected·Jun 21, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuti...
Drugs·221 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labe...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pall...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as ...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Ch...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. ...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pa...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pa...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled ...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product l...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pall...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago,...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product ...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as ...
Surgical Devices·2,225 affected·Jun 21, 2017