Model Catalog: IBI-89017 (89017) (1500T14) (Lot serial: ALL)

1500T14 CARDIAC ABLATION SYSTEM-GENERATOR

Model Catalog: IBI-89017 (89017) (1500T14) (Lot serial: ); Model Catalog: IBI-89018 (89018) (Lot serial: )

1500T14 CARDIAC ABLATION SYSTEM-GENERATOR

1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical, Cardiac Rhythm Management Division

Cardiovascular Devices

(1) - (2) balloon expandable angioplasty catheter for coronary vessels

(1) - (12) Automatic implantable defibrillator, implantable biventricular pacing pulse generator with defibrillation function

in-vitro_medical_device

ivd

In-vitro diagnostics - equipment / products for clinical chemistry

Model Catalog: 04J71-20 (Lot serial: 56944001); Model Catalog: 04J71-20 (Lot serial: 57026001); Model Catalog: 04J71-20 (Lot serial: 57059001); Model Catalog: 04J71-20 (Lot serial: 57673001)

5 ML REACTION VESSELS USED WITH THE M2000SP INSTRUMENT

In-vitro diagnostic products

4J71-20 | 56944001, 57026001, 57059001, 57673001

IVD: Sample processor

5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)List Number: 04J71-20Lot Numbers: 56944001, 57026001, 57059001 and 57673001

Clinical Chemistry and Clinical Toxicology Devices

5mm Thoracic Grasper, Intuitive Surgical Inc

Injections / Infusions / Transfusions / Dialysis

Model No.: 6172ANS, 6170ANS Multiple batch & serial numbers (See attached FSN) UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320

Implantable Pulse Generators

Model: List Number: 04J71-20, Affected: Lots: 56944001, 57026001, 57059001, 57673001

Model: All models, Affected: All lots

Model: All models, Affected: All lots

Abbott Alinity c Creatine Kinase, Abbott Alinity c Creatine Kinase

Abbott Alinity hq Analyzer, Abbott GmbH & Co. KG