August 2019 FDA Med Device Recalls - Acela Medical

FDA Medical Device Recall Series - August 2019

August 2019 FDA Recall List

8/2/2019 Centurion Medical Products Recalls Airway Kit containing Sheridan® Endotracheal Tubes Due to Potential for the Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit

Models Affected:

Kit TC7855

Lots/Distribution Dates:

November 28, 2018 to June 5, 2019

8/2/2019 QIAGEN Recalls Filter Tips for use with the QIAsymphony SP/AS Instruments Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results

Models Affected:

REF 997024

Lots:

0605020019
0605020020

8/5/2019 Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

Models Affected:

CD1377-36C
CD1377-36QC
CD1411-36Q
CD2377-36QC
CD2411-36C
CD2411-36Q

Lots:

All lots manufactured between April 5, 2019 – May 29, 2019

8/12/2019 Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors

Models Affected:

Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1

Lots:

All

8/21/2019 Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow Fluid Warming Disposable Cartridge Due to Potential Risk of Exposure to Elevated Levels of Aluminum

Models Affected:

DYNJ52510A

Lots:

2018090690
2018101190
2018101590
2018121190
2019013190
2019030490
2019040190

8/21/2019 Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication

Models Affected:

DYNJ52510A
DYNJ52509A

Lots:

2018090590
2018112190
2018090690
2018101190
2018101590
2018121190
2019013190
2019030490
2019040190

8/22/2019 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

Models Affected:

SAPIEN 3 Ultra Delivery System

Lots:

All

If your organization needs help coordinating logistics, etc. related to any of the above Recalls, please don’t hesitate to contact us.