The Recall Desk
SevereFDA (Devices)·Z-2319-2015·Announced 2015-08-12

Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation

Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing 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 is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, and the source text describes potential complications including occlusion of blood flow to end organs.

Plain-English summary

Cook Inc. is recalling the Slip-Cath Beacon Tip Catheter, an angiographic catheter used in medical procedures to deliver contrast media and help diagnose occlusion or stenosis. The recall involves 248,167 units of the device, which are designed for percutaneous introduction into the vascular system.

The recall is being conducted due to reports of catheter tip splits and/or separation. These defects can result in a 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.

The affected catheters were distributed worldwide, including in 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. Users of these devices should contact Cook Inc. for further instructions on how to proceed.

The recalled product

Product
Slip-Cath Beacon Tip 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
Manufacturer
Cook Inc.
Category
Medical Device — Angiographic Catheter
Hazard
Affected units
248,167

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: SCBR4.0-35-150-P-NS-0
  • SCBR4.0-35-65-P-NS-RC2
  • SCBR4.0-38-100-P-NS-0
  • SCBR4.0-38-100-P-NS-C2
  • SCBR4.0-38-100-P-NS-DAV
  • SCBR4.0-38-100-P-NS-H1
  • SCBR4.0-38-100-P-NS-HN4
  • SCBR4.0-38-100-P-NS-JB1
  • SCBR4.0-38-100-P-NS-JB2
  • SCBR4.0-38-100-P-NS-KMP
  • SCBR4.0-38-100-P-NS-MAN
  • SCBR4.0-38-100-P-NS-MPA
  • SCBR4.0-38-100-P-NS-MPB
  • SCBR4.0-38-100-P-NS-SIM1
  • SCBR4.0-38-100-P-NS-SIM2
  • SCBR4.0-38-100-P-NS-SIM3
  • SCBR4.0-38-100-P-NS-VERT
  • SCBR4.0-38-125-P-NS-0
  • SCBR4.0-38-125-P-NS-DAV
  • SCBR4.0-38-125-P-NS-JB1

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

Same manufacturer · Cook Inc.

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Same hazard · device separation

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