Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Recall
- Recall Number
- Z-0840-2012
- Event Number
- 60463
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- DTQ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 13, 2012
- Posted
- January 24, 2012
- Terminated
- December 3, 2012
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586
Description
Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
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.
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.
Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam
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