Separator, Automated, Blood Cell And Plasma, Therapeutic

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.

AMICUS Exchange Kit;

Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s

Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US.

Defective product may result in decreased efficacy.

Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.

Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215.

Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.

Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215.

An additional air detection system is being added to all existing systems to detect air in the system's return line.

The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Devic

Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.

Fresenius Red Blood Cell Set, Catalog Number 9007601.

Potential for patient hematocrit dropped to levels lower than expected post-treatment.

Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

Under specific conditions, apheresis machine could return up to 60mL of air to the patient.