🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Class I - Dangerous
🏥 Medical Devices Recalled: November 24, 2020 Cook Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 13135874, 13141336, 13162743, 13168158, 13192089, 13214454, 13229690, 13237656, 13265339, 13297262, 13312708, 13320587, 13323491, 13342872, 13349041, 13363230, 13382710, 13407498, NS13140914, NS13219558, NS13221811, NS13246568, NS13265338, NS13291878, NS13291879, NS13312707, NS13342874, NS13349040, NS13360428, NS13372495
  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:
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Product Codes/Lot Numbers:

Lot Numbers: 13135874, 13141336, 13162743, 13168158, 13192089, 13214454, 13229690, 13237656, 13265339, 13297262, 13312708, 13320587, 13323491, 13342872, 13349041, 13363230, 13382710, 13407498, NS13140914, NS13219558, NS13221811, NS13246568, NS13265338, NS13291878, NS13291879, NS13312707, NS13342874, NS13349040, NS13360428, NS13372495

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0606-2021

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