News

• Voluntary Malfunction Summary Reporting Program finalized Aug 16, 2018
• Philips’ Ultrasound Systems Cleared by FDA
• FDA Guidance: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Issued on November 5, 2018

• FDA Extends Malfunction Summary Reporting Program to Combo Products
• FDA Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
• FDA Guidance Document: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
• FDA Guidance Document: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
• FDA Draft Guidance: Principles of Premarket Pathways for Combination Products
• Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry

• Recall > Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results 1/25/19
• Recall > West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions 2/1/19
• Recall > Medex Cardio-Pulmonary, Doing Business as Smiths Medical Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers 2/4/19
• Recall > Swan-Ganz Thermodilution Catheter by Edwards Lifesciences: Class I Recall- Due to Incorrect Assembly 2/5/19
• Consent Decree > Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions 2/6/19
• Warning Letter > Thibiant International, Inc.. CGMP/Finished Pharmaceuticals/Adulterated 3/6/19
• Class I Recall: Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples
• Class I Recall: lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock
• Class I Recall: Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire
• Class I Recall: Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath
• Class 1 Recall: GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking | FDA
• Class I Recall: Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State
•  Class 1 Recall: Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy
•  Class 1 Recall > Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention
• Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples
• Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues
• Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached
• Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks
• Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm
• Class I Recall: Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall.
• Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing
• Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up.
• Class I Recall: Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error
• Class 1 Recall: Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys

 TO BE ANNOUNCED