PlainRecalls
FDA Devices Moderate Class II Terminated

24 Fr 8mm Sft Flow Straight Wir 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

Reported: December 12, 2012 Initiated: November 21, 2012 #Z-0457-2013

Product Description

24 Fr 8mm Sft Flow Straight Wir 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

Details

Units Affected
5760 total
Distribution
Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.
Location
Ann Arbor, MI

Frequently Asked Questions

What product was recalled? ▼
24 Fr 8mm Sft Flow Straight Wir 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. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 5760 total.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2012. Severity: Moderate. Recall number: Z-0457-2013.

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