Terumo Recalls Sarns Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
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 the presence of particulate matter poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 40 units of Sarns Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. The product is indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots. The affected units are identified by Catalog Number 9473 and Lot Number 0689812.
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. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 40
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 9473 Lot Numbers 0689812
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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