FDA-Device2017-05-10Class II
SurFlo IV Catheter
Terumo Medical Corporation
Hazard
According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.
Sold states
US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
Affected count
2,478,200
Manufactured in
950 Elkton Blvd, Elkton, MD, United States
Products
SurFlo IV Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1896-2017Don't want to check this manually?
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