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Cook Inc. - Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated - Class 2 Recall
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Cook Inc. - Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane - Class 2 Recall
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Cook Inc. - Central Venous Tray Triple Lumen Polyurethane Catheter - Class 2 Recall
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Cook Inc. - Central Venous Catheter Set Triple Lumen Polyurethane - Class 2 Recall
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Cook Inc. - Central Venous Catheter Tray Triple Lumen Polyurethane - Class 2 Recall
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - AGC Porous Patellar SM - Class 2 Recall
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - AGC Porous Patellar Med - Class 2 Recall
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neurosurgery - Medtronic Clip Gun Scalp Clip - Class 2 Recall
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Synthes USA - Norian Drillable - Class 2 Recall
Norian Drillable Inject (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - ELAN 4 - Class 2 Recall
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - ELAN 4 - Class 2 Recall
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 ELAN...
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - ELAN 4 - Class 2 Recall
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROSEN BURR D2.7 ELAN 4 1-RING ROSEN BURR+ D2.7 ELAN 4 1-RING ROSEN BURR D3.0 ELAN 4 1-RING ROSEN BURR TC D3.0 ELAN 4 1-RING ROSEN BURR D3.5 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Roche Diabetes Care, Inc. - AccuChek Connect Diabetes Management App - Class 2 Recall
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - ELAN 4 Air System - Class 2 Recall
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

AMEDA, INC. - Purely Yours Breast Pumps - Class 3 Recall
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Acetabular Hip Replacement Components - Class 2 Recall
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - Sterilization wrap - Class 2 Recall
JS Series SterilContainer"S2 System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2018 Category: Medical Devices Source Type: alerts

Zimmer Surgical Inc - A.T.S. 2200TS Tourniquet Systems - Class 2 Recall
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Zimmer Surgical Inc - A.T.S. 4000TS Tourniquet Systems, Personalized Pressure - Class 2 Recall
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. . (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Tibial Impact Pad - Class 2 Recall
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Sanofi Genzyme - SynviscOne - Class 2 Recall
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Keystone Dental Inc - PrimaConnex Implant System - Class 2 Recall
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

OrthoPediatrics Corp - thoracolumbosacral pedicle screw system - Class 2 Recall
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Pentax of America Inc - Video Cystoscope models ECY1570 and ECY1570K - Class 2 Recall
Video Cystoscope models ECY-1570 and ECY-1570K (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, INC - Artis one systems with a DP Transceiver - Class 2 Recall
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Gibson Laboratories LLC - Gibson Bioscience Blastomyces dermatitidis Antiserum - Class 2 Recall
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 15, 2018 Category: Medical Devices Source Type: alerts

Cincinnati Sub-Zero Products LLC - Hemotherm - Class 2 Recall
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Arrow International Inc - Arrow Arterial Catheterization Kit - Class 2 Recall
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Arrow International Inc - ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). - Class 2 Recall
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - Lyophilized Chemistry Calibrator Level 1 and Level 2 - Class 2 Recall
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucos...
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Arrow International Inc - ARROW PICC powered by ARROW VPS Stylet - Class 2 Recall
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

ConforMIS, Inc. - iTotal Posterior Stabilized (PS) Knee Replacement System - Class 2 Recall
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - Titanium Trochanteric Fixation Nail (TFN) - Class 2 Recall
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts

Cepheid - Xpert CT/NG - Class 2 Recall
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

Hologic, Inc - Hologic Panther(R) Fusion(TM) - Class 2 Recall
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

Aesculap Implant Systems LLC - Orthopedic Template - Class 2 Recall
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

C.R. Bard, Inc. - Arctic Sun ArcticGel Pads - Class 3 Recall
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - Collarless Cementless Hip Stem - Class 2 Recall
CORAIL¿ HIGH OFFSET STEM Collarless SIZE 14 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

3M Company - Health Care Business - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket - Class 2 Recall
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - Collared Cementless Hip Stem - Class 2 Recall
CORAIL¿ COXA VARA HIGH OFFSET STEM Collared Size 9 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

3M Company - Health Care Business - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket - Class 2 Recall
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2018 Category: Medical Devices Source Type: alerts

Medtronic Sofamor Danek USA Inc - Medtronic ANGLED DRILL - Class 2 Recall
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

GE Medical Systems China Co., Ltd. - Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 - Class 2 Recall
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

GE Medical Systems China Co., Ltd. - Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 - Class 2 Recall
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Covidien Emprint Percutaneous Antenna with Thermosphere Technology - Class 2 Recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Covidien Emprint Percutaneous Antenna with Thermosphere Technology - Class 2 Recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Covidien Emprint Percutaneous Antenna with Thermosphere Technology - Class 2 Recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Covidien Emprint Percutaneous Antenna with Thermosphere Technology - Class 2 Recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Covidien Emprint Percutaneous Antenna with Thermosphere Technology - Class 2 Recall
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2018 Category: Medical Devices Source Type: alerts