🔍 RecallPedia

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

Class I - Dangerous
🏥 Medical Devices Recalled: January 20, 2016 Cook Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304
  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:
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
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, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

Product Codes/Lot Numbers:

Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

Distribution:

Distributed in: CA, FL, OK, OH, MI, TX, NJ, NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0865-2016

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