Large Roller Pump 6" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indica

FDA device recall Z-2738-2011 · posted 2011-07-06 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.

Action taken

Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated March 21, 2011. The letter identified the product, the problem and the action needed to be taken by the customer. An additional URGENT MEDICAL DEVICE RECALL correction notification and cover letter was sent to all consignees on XX/XX/XX to explain the reason for the expansion of the recall and will provide an update to the timing of implementation of the field correction. Expansion now includes devices manufactured between 2006 and March 2012. The correction strategy is to issue the customers a letter and addendum to the Operator's Manual that specifies what the user should do in the event of a tube clamp failure for any reason. The letter states that the firm is still investigating the issue and the correction. The letter states that in the coming months when a resolution is identified, consignees may be contacted to make arrangements for a upgrade to the system. There is no specific timeline for the correction to be made. If you have any further questions, please call a Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours Monday - Friday, 8 Am - 6 Pm EST.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

111 devices.

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong,

Date initiated

2011-03-31

Date posted

2011-07-06

Date terminated

2013-08-28

Location

Ann Arbor, MI