Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extrac

FDA device recall Z-0839-2012 · posted 2012-01-24 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1.

Action taken

TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551. Roller pumps with affected cables will have the cables assembly replaced. For questions regarding this recall call 1-800-521-2818.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTQ

Quantity affected

44

Distribution

Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam

Date initiated

2012-01-13

Date posted

2012-01-24

Date terminated

2012-12-03

Location

Ann Arbor, MI

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