Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo is recalling 30 units of Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 used in surgery where particulate contamination poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 30 units of Sarns Soft-Flow Aortic Cannulas. The affected product is the 8.0 mm (24 Fr) OD model with a 3/8" connector and 14" (36 cm) length, indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The specific lot number affected is 0677302, and the catalog number is 5841.
The product was distributed worldwide, including the United States (specifically DC, MO, TX, OK, LA, MA, CA, WI, and MI) and Canada. Healthcare providers and facilities should stop using the affected units and contact Terumo Cardiovascular Systems for further instructions.
The recalled product
- Product
- Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 30
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 (1)
- Catalog Number 5841 Lot Numbers 0677302
Distribution
Part of a larger recall action
This product is one of 4 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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