X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 074 07 11 000
Date submitted: 7/18/2011
Manufacturer:Haemonetics Corp
Device Type:Collection sets, Plasma Collection HS bowl
Description:Collection sets, Plasma Collection HS bowl, used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient.
Medical Device Identifier:Model: 622HS-00, 623HS-00, 625HS-00, 782HS-P
Reason of Field Safety Corrective Action:There are particulates being generated in rare instances during collection with the 625-HS plasma collection sets.
Remedy Action:Studies are being conducted to ascertain the nature of the particulates and the size. Plasma collection may continue using the 625-HS for purposes of fractionation. Plasma collection for therapeutic use should be suspended with the HS-core. Plasma currently in storage and intended for transfusion should be transfused with filters of a maximum pore size of 170 microns.
Athorized Representative/Importer/Distributor:Fuad Abdul Jalil Al Fadhli & Sons, Riyadh, (01) 4550807
Report Source:NCAR
Source Ref. Number:FR-2011-07-13-033
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments