Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
What this means for you
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, 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 Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. The recall was initiated after in-process inspections identified exposed basket wire on certain product lots of these devices.
The affected devices are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The specific product configuration involved is the 32/40 Fr cannula with a 1/2" connector and 15" (38 cm) length, identified by Catalog Number 4935. These devices are intended for use up to 6 hours.
The recall covers worldwide distribution, including the United States and international markets such as 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 further instructions.
The recalled product
- Product
- Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
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 4935
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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