FDAFDA · Food and drugs·Recall number Z-0460-2013
18 Fr 6mm Sft Flow Ang Wire 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.
Published December 12, 2012 · Recall initiated: November 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- 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.
- Lot
- catalog number: 7072 and lot number: 0602542, 0614871, and 0620810.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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