The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

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…
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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