Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. C

FDA device recall Z-2030-2014 · posted 2014-07-11 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

Action taken

Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.

Root cause

Device Design

Status

Terminated

Product code

KFM

Quantity affected

256 kits

Distribution

Nationwide Distribution

Date initiated

2014-04-14

Date posted

2014-07-11

Date terminated

2016-09-07

Location

Elkton, MD

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