Reported Jul 4, 2012 · Terminated
CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated…
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?
- CUSTOM CPB CATHETER KIT-DR
- Product UsageThe Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures
- Lot codes and dates
- Catalog number80001-01
- and lot number
MG21MM04NA24ND21NK01NM31and PA30
- Amount recalled
- 53,139 (each) in total
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
Why it was recalled
During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the
This product could cause temporary or reversible health problems — stop using it.
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