🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 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: 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235
  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-7.0-35-70-RB-HFANL1-HC, Order Number G56227 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: 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0605-2021

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