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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:145892

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.

Official recall number

Z-2611-2016

Evidence summary

Product code
DQO
Recall status
Terminated
Event initiated
April 15, 2016
Root cause
Unknown/Undetermined by firm
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-2611-2016

Field note

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