🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 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: 13143098, 13143099, 13143100, 13145952, 13145953, 13145955, 13150444, 13150446, 13159696, 13159697, 13159706, 13159708, 13166164, 13166165, 13166168, 13175473, 13175474, 13175480, 13178582, 13186336, 13192068, 13192074, 13211826, 13211827, 13214440, 13217125, 13217126, 13221802, 13223830, 13223831, 13229680, 13231823, 13231824, 13240026, 13240027, 13243203, 13246547, 13246566, 13252353, 13260022, 13260023, 13265330, 13265331, 13265335, 13268038, 13279080, 13281540, 13281800, 13281801, 13286656, 13286658, 13286659, 13286660, 13286662, 13288115, 13304447, 13306333, 13306334, 13307178, 13307189, 13315200, 13315217, 13320585, 13320594, 13329232, 13329248, 13332167, 13334774, 13334775, 13342868, 13349026, 13352485, 13366188, 13366191, 13366194, 13366195, 13366196, 13369415, 13369426, 13380379, 13382712, 13391138, 13391139, 13396128, 13404831, 13404832, 13416497, 13420104, 13420105, 13281802X, NS13315219, NS13315220, NS13329249, NS13334773, NS13349037, NS13352484, NS13352486, NS13401845, NS13426336
  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-6.0-35-70-RB-HFANL0-HC, Order Number G56221 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: 13143098, 13143099, 13143100, 13145952, 13145953, 13145955, 13150444, 13150446, 13159696, 13159697, 13159706, 13159708, 13166164, 13166165, 13166168, 13175473, 13175474, 13175480, 13178582, 13186336, 13192068, 13192074, 13211826, 13211827, 13214440, 13217125, 13217126, 13221802, 13223830, 13223831, 13229680, 13231823, 13231824, 13240026, 13240027, 13243203, 13246547, 13246566, 13252353, 13260022, 13260023, 13265330, 13265331, 13265335, 13268038, 13279080, 13281540, 13281800, 13281801, 13286656, 13286658, 13286659, 13286660, 13286662, 13288115, 13304447, 13306333, 13306334, 13307178, 13307189, 13315200, 13315217, 13320585, 13320594, 13329232, 13329248, 13332167, 13334774, 13334775, 13342868, 13349026, 13352485, 13366188, 13366191, 13366194, 13366195, 13366196, 13369415, 13369426, 13380379, 13382712, 13391138, 13391139, 13396128, 13404831, 13404832, 13416497, 13420104, 13420105, 13281802X, NS13315219, NS13315220, NS13329249, NS13334773, NS13349037, NS13352484, NS13352486, NS13401845, NS13426336

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0600-2021

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