The Recall Desk
HighFDA (Devices)·Z-1393-2017·Announced 2017-03-08

Cook Inc. Recalls TriForce Peripheral Crossing Sets Due to Blood Loss Reports

Cook Inc. is recalling 1,875 TriForce Peripheral Crossing Sets because a specific valve design is associated with increased reports of blood loss.

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 reported adverse events (blood loss) that could delay procedures, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported as severe or fatal.

Plain-English summary

Cook Inc. is recalling 1,875 units of the TriForce Peripheral Crossing Set. The device is intended to be percutaneously introduced into blood vessels to support a wire guide during peripheral interventions and for the injection of radiopaque contrast media. The affected products are packaged in Tyvek-film sterilizable outer pouches.

The recall is being conducted because devices using a specific hemostatic valve design, referred to as a "blue" valve or polyisoprene valve, have an increase in reports of blood loss. This issue could result in a delay in the procedure and blood loss from patients.

The affected units were distributed worldwide, including to all 50 U.S. states, the District of Columbia, and various international locations such as Canada, the United Kingdom, and several countries in Europe, the Middle East, and Africa. The distribution also included VA/DOD facilities. Consumers and healthcare providers should stop using the affected devices and contact Cook Inc. for further instructions.

The recalled product

Product
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interv
Manufacturer
Cook Inc.
Category
Medical Device — Interventional Cardiology
Hazard
Affected units
1,875

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)

  • RPN #
  • 5136679 KCXS-5.0-35-100-RB-0/0-HC 8/7/2014 8/7/2017
  • 5197803 KCXS-5.0-35-100-RB-0/0-HC 8/21/2014 8/21/2017
  • 5219620 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017
  • 5263513 KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017
  • 5263513X KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017
  • 5306527 KCXS-5.0-35-100-RB-0/0-HC 10/9/2014 10/9/2017
  • 5380279 KCXS-5.0-35-100-RB-0/0-HC 11/3/2014 11/3/2017
  • 5491296 KCXS-5.0-35-100-RB-0/0-HC 1/7/2015 1/7/2018
  • 5628924 KCXS-5.0-35-100-RB-0/0-HC 2/27/2015 2/27/2018
  • 5710455 KCXS-5.0-35-100-RB-0/0-HC 4/14/2015 4/14/2018
  • 5768551 KCXS-5.0-35-100-RB-0/0-HC 6/9/2015 6/9/2018
  • 5785293 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018
  • 5785296 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018
  • 5832319 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018
  • 5832319X KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018
  • 5899897 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018
  • 6113669 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018
  • 6113672 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018
  • NS5216411 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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Same hazard · blood loss

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