Terumo Medical Corporation recalls SurFlo IV Catheter

Recall date

August 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1896-2017

FDA classification

Class II

Brand / firm

Terumo Medical Corporation

Sold / distributed

US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SurFlo IV Catheter