FDA Device recall Z-2318-2015
Beacon Tip Royal Flush Plus High-Flow Catheter
- FDA Device
- Class I
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class I recall of Beacon Tip Royal Flush Plus High-Flow Catheter by Cook, citing reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occlud….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2318-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-07-02 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cook |
| Distribution | US |
Product
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Reason
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Identifiers
| code_info | All lots of the following Product numbers: HNR4.0-35-100-P-10S-0, HNR4.0-35-100-P-10S-CFP, HNR4.0-35-100-P-10S-PI…All lots of the following Product numbers: HNR4.0-35-100-P-10S-0, HNR4.0-35-100-P-10S-CFP, HNR4.0-35-100-P-10S-PIG, HNR4.0-35-100-P-6S-VCF, HNR4.0-35-100-P-NS-0, HNR4.0-35-100-P-NS-DAV, HNR4.0-35-100-P-NS-SIM1, HNR4.0-35-100-P-NS-SIM2, HNR4.0-35-100-ST-10S-0, HNR4.0-35-100-ST-10S-PIG, HNR4.0-35-100-ST-6S-PED, HNR4.0-35-110-P-10S-PIG, HNR4.0-35-120-P-6S-PED, HNR4.0-35-120-ST-6S-PED, HNR4.0-35-125-P-10S-0, HNR4.0-35-125-P-10S-PIG, HNR4.0-35-50-P-NS-0, HNR4.0-35-65-P-8S-VCF, HNR4.0-35-70-P-10S-0, HNR4.0-35-70-P-10S-CFP, HNR4.0-35-70-P-10S-PIG, HNR4.0-35-70-P-4S-PED, HNR4.0-35-70-P-6S-PED, HNR4.0-35-70-P-NS-0, HNR4.0-35-70-ST-10S-0, HNR4.0-35-70-ST-10S-PIG, HNR4.0-35-70-ST-6S-PED, HNR4.0-35-90-P-10S-0, HNR4.0-35-90-P-10S-CFP, HNR4.0-35-90-P-10S-PIG, HNR4.0-35-90-P-6S-PED, HNR4.0-35-90-P-8S-VCF, HNR4.0-35-90-P-NS-0, HNR4.0-35-90-ST-10S-0, HNR4.0-35-90-ST-10S-PIG |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2318-2015%22
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