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 vascular system over an appropriately sized wire guide.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, HNBR4.0-35-125-P-NS-DAV, HNBR4.0-35-125-P-NS-H1, HNBR4.0-35-125-P-NS-JB1, HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA, HNBR4.0-35-125-P-NS-SIM2, HNBR4.0-35-125-P-NS-VERT, HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG, HNBR4.0-35-40-P-NS-KMP, HNBR4.0-35-65-P-NS-0, HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2, HNBR4.0-35-65-P-NS-C3, HNBR4.0-35-65-P-NS-DAV, HNBR4.0-35-65-P-NS-H1, HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP, HNBR4.0-35-65-P-NS-MPA, HNBR4.0-35-65-P-NS-RC1, HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC, HNBR4.0-35-65-P-NS-RIM, HNBR4.0-35-65-P-NS-SIM1, HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1, HNBR4.0-35-80-P-NS-C2, HNBR4.0-35-80-P-NS-JL2, HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3, HNBR4.0-35-80-P-NS-JR1, HNBR4.0-35-80-P-NS-JR2, HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH, HNBR4.0-35-80-P-NS-RLG, HNBR4.0-35-80-P-NS-VS, HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2, HNBR4.0-35-80-P-NS-VS3, HNBR4.0-NT-100-P-NS-H1, HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM, HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0, HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2, HNBR4.1-35-100-P-NS-DAV, HNBR4.1-35-100-P-NS-H1, HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2, HNBR4.1-35-100-P-NS-JB3, HNBR4.1-35-100-P-NS-KMP, HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1, HNBR4.1-35-100-P-NS-SIM1, HNBR4.1-35-100-P-NS-SIM2, HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT, HNBR4.1-35-100-P-NS-WNBG, HNBR4.1-35-110-P-NS-JB1, HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG, HNBR4.1-35-120-P-NS-JB2, HNBR4.1-35-130-P-NS-DAV-T, HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1, HNBR4.1-35-65-P-NS-C2, HNBR4.1-35-65-P-NS-DAV, HNBR4.1-35-65-P-NS-H1, HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP, HNBR4.1-35-65-P-NS-LEV1, HNBR4.1-35-65-P-NS-MPA, HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2, HNBR4.1-35-65-P-NS-RDC, HNBR4.1-35-65-P-NS-RIM, HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1, HNBR4.1-35-75-P-NS-CHG-D, HNBR4.1-35-80-P-NS-C1, HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2, HNBR4.1-35-80-P-NS-JL2.5, HNBR4.1-35-80-P-NS-JL3, HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2, HNBR4.1-35-80-P-NS-JR3.5, HNBR4.1-35-80-P-NS-RC1, HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG, HNBR4.1-35-80-P-NS-VS, HNBR4.1-35-80-P-NS-VS2, HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1, HNBR4.1-NT-80-P-NS-RC1, HNBR4.1-NT-80-P-NS-RH, HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG, HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 vascular system over an appropriately sized wire guide.

Product Codes/Lot Numbers:

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, HNBR4.0-35-125-P-NS-DAV, HNBR4.0-35-125-P-NS-H1, HNBR4.0-35-125-P-NS-JB1, HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA, HNBR4.0-35-125-P-NS-SIM2, HNBR4.0-35-125-P-NS-VERT, HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG, HNBR4.0-35-40-P-NS-KMP, HNBR4.0-35-65-P-NS-0, HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2, HNBR4.0-35-65-P-NS-C3, HNBR4.0-35-65-P-NS-DAV, HNBR4.0-35-65-P-NS-H1, HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP, HNBR4.0-35-65-P-NS-MPA, HNBR4.0-35-65-P-NS-RC1, HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC, HNBR4.0-35-65-P-NS-RIM, HNBR4.0-35-65-P-NS-SIM1, HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1, HNBR4.0-35-80-P-NS-C2, HNBR4.0-35-80-P-NS-JL2, HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3, HNBR4.0-35-80-P-NS-JR1, HNBR4.0-35-80-P-NS-JR2, HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH, HNBR4.0-35-80-P-NS-RLG, HNBR4.0-35-80-P-NS-VS, HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2, HNBR4.0-35-80-P-NS-VS3, HNBR4.0-NT-100-P-NS-H1, HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM, HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0, HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2, HNBR4.1-35-100-P-NS-DAV, HNBR4.1-35-100-P-NS-H1, HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2, HNBR4.1-35-100-P-NS-JB3, HNBR4.1-35-100-P-NS-KMP, HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1, HNBR4.1-35-100-P-NS-SIM1, HNBR4.1-35-100-P-NS-SIM2, HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT, HNBR4.1-35-100-P-NS-WNBG, HNBR4.1-35-110-P-NS-JB1, HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG, HNBR4.1-35-120-P-NS-JB2, HNBR4.1-35-130-P-NS-DAV-T, HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1, HNBR4.1-35-65-P-NS-C2, HNBR4.1-35-65-P-NS-DAV, HNBR4.1-35-65-P-NS-H1, HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP, HNBR4.1-35-65-P-NS-LEV1, HNBR4.1-35-65-P-NS-MPA, HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2, HNBR4.1-35-65-P-NS-RDC, HNBR4.1-35-65-P-NS-RIM, HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1, HNBR4.1-35-75-P-NS-CHG-D, HNBR4.1-35-80-P-NS-C1, HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2, HNBR4.1-35-80-P-NS-JL2.5, HNBR4.1-35-80-P-NS-JL3, HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2, HNBR4.1-35-80-P-NS-JR3.5, HNBR4.1-35-80-P-NS-RC1, HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG, HNBR4.1-35-80-P-NS-VS, HNBR4.1-35-80-P-NS-VS2, HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1, HNBR4.1-NT-80-P-NS-RC1, HNBR4.1-NT-80-P-NS-RH, HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG, HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2317-2015

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