Terumo Cardiovascular Systems is recalling some Advanced Perfusion System 1 products

Ronen E

Problem Solver
Staff member
Moderator
#1
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm306171.htm?source=govdelivery

PRODUCT
1) Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-1320-2012;

2)Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall #Z-1321-2012
CODE
1) Lot numbers: 0011-0610, 1001-1034, 1037-1049, 1100, 1103-1445, and 1447-1449;

2) Lot numbers: 0006-0066, 0100-0322, 1001-1027, 1100-1434, and 1436
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letters on March 16, 2012. Firm initiated recall is ongoing.
REASON
Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery.
VOLUME OF PRODUCT IN COMMERCE
1,642 units
DISTRIBUTION
Nationwide and Internationally
I surely wouldn't want that pump to jam during my cardioplegia :(

Unfortunately I couldn't find a related announcement on Terumo CVS's website.
 
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Ajit Basrur

Staff member
Admin
#2
Re: Terumo Cardiovascular Systems is recalling some Advanced Perfusion System 1 produ

Ronen,

I am getting a feeling that the Corporations do not put up the Recall notices on their company website. In earlier case, MOOG do not have the Press Release on their website till date :(
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Terumo Cardiovascular Systems is recalling some Advanced Perfusion System 1 produ

I wonder why.
I thought that in cases where the recall is obviously a safety measure, and involves lay users, it would be in the company's interest to let the public know in any effective way they can.
In my opinion an announcement such as that in the company's website would not taint their reputation, but on the contrary - present them as being responsible and actually caring for the public's good.
 
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