The Recall Desk
HighFDA (Devices)·Z-2317-2015·Announced 2015-08-12

Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters

Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (occlusion of blood flow) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters, which are angiographic catheters used in procedures to deliver contrast media and help diagnose occlusion or stenosis. The recall is due to reports of catheter tip splits and/or separation.

The affected units are distributed worldwide, including the United States (nationwide including Puerto Rico and US Virgin Islands) and numerous other countries. The recall covers all lots of specific product numbers listed in the agency's documentation.

The hazard associated with this recall is the potential for loss of device function, the need for medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. Consumers and healthcare providers should stop using the affected catheters and contact the manufacturer for further instructions.

The recalled product

Product
Beacon Tip Torcon NB Advantage 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 vascula
Manufacturer
Cook Inc.
Category
Medical Device — Angiographic Catheter
Hazard
Affected units
451,550

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 following Product numbers: HNBR4.0-35-100-P-NS-0
  • HNBR4.0-35-100-P-NS-C1
  • HNBR4.0-35-100-P-NS-C2
  • HNBR4.0-35-100-P-NS-CANADA-041480
  • HNBR4.0-35-100-P-NS-DAV
  • HNBR4.0-35-100-P-NS-H1
  • HNBR4.0-35-100-P-NS-JB1
  • HNBR4.0-35-100-P-NS-JB2
  • HNBR4.0-35-100-P-NS-JB3
  • HNBR4.0-35-100-P-NS-JIM
  • HNBR4.0-35-100-P-NS-KMP
  • HNBR4.0-35-100-P-NS-MPA
  • HNBR4.0-35-100-P-NS-O1
  • HNBR4.0-35-100-P-NS-SIM1
  • HNBR4.0-35-100-P-NS-SIM2
  • HNBR4.0-35-100-P-NS-SIM3
  • HNBR4.0-35-100-P-NS-VERT
  • HNBR4.0-35-100-P-NS-VTK
  • HNBR4.0-35-100-P-NS-WNBG
  • HNBR4.0-35-125-P-NS-0

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 →

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