Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate
Terumo CVS is recalling 90 units of Sarns Soft-Flow Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves particulate contamination exceeding specifications, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 90 units of Sarns Soft-Flow Aortic Cannulas. The affected product is the 8.0 mm (24 Fr) OD model with a 3/8" connector, 14" (36 cm) long, indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The specific lot number is 0677300 and the catalog number is 5762.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. This issue was found on certain product lots of Sarns Soft-Flow Aortic Cannulae and Sarns Venous Return Cannulae.
The affected units were distributed worldwide, including the United States (DC and the states of MO, TX, OK, LA, MA, CA, WI, and MI) and Canada. Users should stop using the affected product and contact Terumo Cardiovascular Systems Corporation for further instructions.
The recalled product
- 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" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 90
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 5762 Lot Numbers 0677300
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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