Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
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 with a structural defect (exposed wire) that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Dual-stage Venous Return Cannulae and Sarns Malleable Dual-stage Venous Return Cannulae. The recall was initiated after in-process inspections identified exposed basket wire on certain product lots. These devices are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The affected products include the Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare, Catalog Number 16472. The distribution pattern includes the United States (specifically CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX) and international locations including the United Arab Emirates, Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
Healthcare providers and facilities should stop using the affected lots and contact Terumo CVS for instructions on return or replacement. The source text does not specify the exact number of affected units or specific lot numbers beyond the general identification of 'certain product lots.'
The recalled product
- Product
- Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
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 16472
Distribution
Part of a larger recall action
This product is one of 7 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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