Recall Z-1896-2017— Terumo Medical Corporation

Name: FDA recall Z-1896-2017
Creator: U.S. Food and Drug Administration
Published: 2015-08-05

Class II · Terminated

Class II FDA medical device recall by Terumo Medical Corporation, initiated 2015-08-05, terminated 2017-05-01. It names one FDA 510(k) clearance: K891087. Product: SurFlo IV Catheter. Reason: 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..

Recalling firm: Terumo Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Terminated: 2017-05-01
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K891087 — TERUMO SURFLO(R) I.V. CATHETERTerumo Medical Corp.·cleared 1989-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SurFlo IV Catheter

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.