🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 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: 13205314, 13205322, 13229673, 13229685, 13234800, 13249450, 13256702, 13262338, 13265332, 13265337, 13279097, 13288121, 13291877, 13297249, 13297260, 13297261, 13301872, 13310761, 13312706, 13318040, 13318062, 13332170, 13346105, 13349029, 13354271, 13354272, 13357259, 13360427, 13360442, 13366230, 13372465, 13372469, 13375211, 13375227, 13377002, 13391151, 13398856, 13426338, 13329254X, 13332169X, 13342871X
  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-7.0-35-55-RB-HFANL0-HC, Order Number G56232 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: 13205314, 13205322, 13229673, 13229685, 13234800, 13249450, 13256702, 13262338, 13265332, 13265337, 13279097, 13288121, 13291877, 13297249, 13297260, 13297261, 13301872, 13310761, 13312706, 13318040, 13318062, 13332170, 13346105, 13349029, 13354271, 13354272, 13357259, 13360427, 13360442, 13366230, 13372465, 13372469, 13375211, 13375227, 13377002, 13391151, 13398856, 13426338, 13329254X, 13332169X, 13342871X

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0602-2021

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