Recall Z-0462-2013— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0462-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-21

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-11-21, terminated 2013-04-23. It names one FDA 510(k) clearance: K934127. Product: 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.. Reason: The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl.

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-11-21
Terminated: 2013-04-23
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K934127 — SARNS LOW JETTING AORTIC ARCH CANNULA3M Health Care, Sarns·cleared 1994-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Data sourced from openFDA. This site is unofficial and independent of the FDA.