Reported Jan 23, 2013 · Terminated
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Road · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
- Lot codes and dates
- Lot number
06801220680751and
- Catalog number12325
- Lot number
- Amount recalled
- 6830 total all products
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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