Terumo Recalls SurFlo IV Catheters Due to Potential Catheter Breakage
Terumo Medical Corporation is recalling SurFlo IV Catheters because a small percentage may have damage that allows the catheter to break during withdrawal.
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 (catheter breakage) that poses a risk of harm to patients, 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 Medical Corporation is recalling approximately 2,478,200 units of SurFlo IV Catheters. These devices are used to access the human peripheral vascular system for short-term use (less than 30 days) to infuse fluids into patients.
The recall is due to a defect where a small percentage of the catheters in the affected lots may have damage to the ETFE catheter. This damage may allow the catheter to break during withdrawal.
The product was distributed in the US to distribution companies with multiple locations and directly to end users and hospitals. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- SurFlo IV Catheter
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 2,478,200
Distribution
Distribution scope not specified by the agency.
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