Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange recall: Particulate Matter
Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8"…
Why was Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange recalled?
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow¿ Aortic Cannulae and Sarns" Venous Return Cannulae.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 5762 Lot Numbers 0677300
- Product
- Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8"…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 90 units
- Distribution
- Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada.
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)