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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 040 12 14 000
Date submitted: 12/4/2014
Manufacturer:Hospira Inc
Device Type:Hospira Plum Blood Sets
Description:Infusion pump
Medical Device Identifier:List Numbers : 14202-92-28, 14205-92-28, 14212-92-28

Lot Numbers : 220485H, 334165H, 401245H, 331925H, 334085H
Reason of Field Safety Corrective Action:Potential to Puncture the Outer Wall of Non-ISO 3826-1 Compliant Blood Bags
Remedy Action:Determine if your facility has any of the lot numbers above, which are non-ISO 3826-1 compliant.

If your facility does have non-ISO 3826-1 compliant blood bags, please follow the actions detailed below:

-Please check your inventory and immediately quarantine any of the affected Hospira sets listed above.

-Inform healthcare professionals in your organization of this notification.

-If impacted, work with your local Hospira office to arrange return of the affected Hospira sets.

Should your facility experience leaking blood bags due to puncturing the outer wall during insertion of the piercing pin, report the issue to your local Hospira office.
Athorized Representative/Importer/Distributor:AL-KAMAL Import
Report Source:NCMDR
Source Ref. Number:6B2BC209A3204
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hospira Inc.pdf