Recall Z-2611-2016— Cook Inc.

Class II FDA medical device recall by Cook Inc., initiated 2016-04-15, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.. Reason: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs..

Recalling firm

Cook Inc.

Classification

Class II

Status

Terminated

Initiated

2016-04-15

Terminated

2017-08-04

Firm location

Bloomington, IN, United States

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