The Recall Desk
SevereFDA (Devices)·Z-2318-2015·Announced 2015-08-12

Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device defect that may result in complications from occluded blood flow to end organs, meeting the criteria for significant injury reports or structural defects.

Plain-English summary

Cook Inc. is recalling the Beacon Tip Royal Flush Plus High-Flow Catheter, an angiographic catheter used in procedures to deliver contrast media and diagnose occlusion or stenosis. The recall involves 268,169 units distributed worldwide, including the United States, Puerto Rico, and the US Virgin Islands.

The recall was initiated due to reports of catheter tip splits and/or separation. These defects may result in the loss of device function, the need for medical intervention to retrieve the separated segment, or complications if the separated tip occludes blood flow to end organs.

Healthcare providers should stop using the affected catheters and contact Cook Inc. for further instructions. The affected product numbers are listed in the structured product information, covering various configurations of the HNR4.0-35 series.

The recalled product

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 th
Manufacturer
Cook Inc.
Category
Medical Device — Angiographic Catheter
Hazard
Affected units
268,169

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

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Same hazard · device separation

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