Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a foreign substance can be dislodged, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling specific lots of the Sarns High-Flow Aortic Arch Cannula, a medical device used for perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall involves 133,793 units distributed nationwide in the United States and in various countries worldwide.
The recall was initiated because a foreign substance was discovered on the outer surface of some cannulae connectors during the production of one lot. A preliminary investigation determined that the substance was likely deposited during the molding process and can be dislodged from the cannula surface. The exact composition of the particles has not been fully identified in the provided text.
Healthcare providers and facilities that have received these products should stop using the affected cannulae and contact Terumo CVS for instructions on return or replacement. The affected catalog number is 80004-02, and the specific lot codes are MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.
The recalled product
- Product
- CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 133,793
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Catalog number: 80004-02 and Lot code: MG07
- MK02
- MM11
- MN15
- MP13
- ND28
- NE25
- NN21
- and PA23.
Distribution
Part of a larger recall action
This product is one of 11 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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