Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) Product Usage: The Terumo Advanced Perfusi

FDA device recall Z-0300-2012 · posted 2011-11-29 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed

Action taken

Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTQ

Quantity affected

1 unit

Distribution

Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.

Date initiated

2011-11-10

Date posted

2011-11-29

Date terminated

2012-09-06

Location

Ann Arbor, MI

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