Agency classClass IIOur severity:High FDA (Devices)·Z-1835-2012·Announced 2012-06-27

Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.

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 medical device used in surgery where a foreign substance can be dislodged, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling Sarns Flexible Arterial Cannulas (6.7 mm, 20 Fr) with 3/8" connectors. The recall affects 133,793 units distributed nationwide in the United States and in 21 other countries.

The recall was initiated because a foreign substance was found on the outer surface of some cannula connectors during production. Terumo CVS' preliminary investigation determined that the substance can be dislodged from the cannula surface and was likely deposited during the molding process. The exact composition of the particles has not been fully determined in the provided text.

Healthcare facilities and consumers should stop using the affected cannulas immediately. The affected catalog number is 13010, and the specific lot codes are 0590855, 0593791, 0597307, 0603718, 0616892, 0624831, 0629341, 0634937, 0636270, 0644444, 0646144, 0653230, 0666586, and 0669487.

The recalled product

Product: SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. 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
Category: Medical Device — Surgical Cannula
Hazard: foreign-substance
contamination
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 (14)

Catalog number: 13010 and Lot codes: 0590855
0593791
0597307
0603718
0616892
0624831
0629341
0634937
0636270
0644444
0646144
0653230
0666586
and 0669487.

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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.

See all 11 products in this recall →

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Same hazard · foreign substance