🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 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: 13135825, 13138939, 13138940, 13143095, 13143096, 13143097, 13150435, 13150438, 13150439, 13150440, 13150441, 13153382, 13153386, 13153387, 13155287, 13155288, 13155295, 13155296, 13158205, 13159698, 13159699, 13159701, 13159702, 13159703, 13159704, 13159705, 13166156, 13166160, 13166161, 13166162, 13172674, 13172679, 13172680, 13172681, 13175467, 13175468, 13175472, 13180819, 13186324, 13186325, 13186326, 13186329, 13186331, 13189188, 13189189, 13189190, 13189195, 13189196, 13189197, 13192073, 13197482, 13200417, 13200418, 13202955, 13202956, 13205308, 13207461, 13207462, 13207463, 13207464, 13211828, 13214464, 13214465, 13217129, 13217132, 13217133, 13217134, 13217135, 13217136, 13217137, 13221800, 13221806, 13221807, 13226796, 13226797, 13226798, 13226799, 13226800, 13226801, 13231821, 13237671, 13237672, 13240020, 13240021, 13240022, 13240023, 13240024, 13240025, 13246564, 13246565, 13256701, 13256707, 13256708, 13256709, 13256710, 13256711, 13262346, 13262347, 13268037, 13281553, 13281792, 13281793, 13281794, 13281795, 13281796, 13281797, 13281798, 13281799, 13291872, 13291875, 13294539, 13294540, 13294541, 13294542, 13297253, 13297254, 13297255, 13297256, 13297257, 13301868, 13301869, 13301870, 13304446, 13307201, 13307202, 13307203, 13307204, 13310756, 13310757, 13310758, 13312696, 13312701, 13312702, 13312703, 13315213, 13315214, 13315215, 13315216, 13318057, 13318058, 13320584, 13320592, 13320593, 13329231, 13329243, 13329244, 13329245, 13329247, 13332165, 13332166, 13334765, 13334766, 13334772, 13342864, 13342865, 13342866, 13346103, 13346104, 13346117, 13349025, 13349035, 13349036, 13352476, 13352477, 13352478, 13352479, 13352480, 13352481, 13352482, 13352483, 13357255, 13357256, 13360433, 13360434, 13360435, 13360436, 13360437, 13360439, 13366224, 13366225, 13372603, 13372604, 13375216, 13375217, 13375218, 13375219, 13375220, 13376996, 13380383, 13382713, 13382714, 13382715, 13382716, 13388322, 13388323, 13388324, 13391160, 13398852, 13423953, 13432833, 13446739, 13446740, 13455461, 13334771X
  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-6.0-35-55-RB-HFANL0-HC, Order Number G56231 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: 13135825, 13138939, 13138940, 13143095, 13143096, 13143097, 13150435, 13150438, 13150439, 13150440, 13150441, 13153382, 13153386, 13153387, 13155287, 13155288, 13155295, 13155296, 13158205, 13159698, 13159699, 13159701, 13159702, 13159703, 13159704, 13159705, 13166156, 13166160, 13166161, 13166162, 13172674, 13172679, 13172680, 13172681, 13175467, 13175468, 13175472, 13180819, 13186324, 13186325, 13186326, 13186329, 13186331, 13189188, 13189189, 13189190, 13189195, 13189196, 13189197, 13192073, 13197482, 13200417, 13200418, 13202955, 13202956, 13205308, 13207461, 13207462, 13207463, 13207464, 13211828, 13214464, 13214465, 13217129, 13217132, 13217133, 13217134, 13217135, 13217136, 13217137, 13221800, 13221806, 13221807, 13226796, 13226797, 13226798, 13226799, 13226800, 13226801, 13231821, 13237671, 13237672, 13240020, 13240021, 13240022, 13240023, 13240024, 13240025, 13246564, 13246565, 13256701, 13256707, 13256708, 13256709, 13256710, 13256711, 13262346, 13262347, 13268037, 13281553, 13281792, 13281793, 13281794, 13281795, 13281796, 13281797, 13281798, 13281799, 13291872, 13291875, 13294539, 13294540, 13294541, 13294542, 13297253, 13297254, 13297255, 13297256, 13297257, 13301868, 13301869, 13301870, 13304446, 13307201, 13307202, 13307203, 13307204, 13310756, 13310757, 13310758, 13312696, 13312701, 13312702, 13312703, 13315213, 13315214, 13315215, 13315216, 13318057, 13318058, 13320584, 13320592, 13320593, 13329231, 13329243, 13329244, 13329245, 13329247, 13332165, 13332166, 13334765, 13334766, 13334772, 13342864, 13342865, 13342866, 13346103, 13346104, 13346117, 13349025, 13349035, 13349036, 13352476, 13352477, 13352478, 13352479, 13352480, 13352481, 13352482, 13352483, 13357255, 13357256, 13360433, 13360434, 13360435, 13360436, 13360437, 13360439, 13366224, 13366225, 13372603, 13372604, 13375216, 13375217, 13375218, 13375219, 13375220, 13376996, 13380383, 13382713, 13382714, 13382715, 13382716, 13388322, 13388323, 13388324, 13391160, 13398852, 13423953, 13432833, 13446739, 13446740, 13455461, 13334771X

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0598-2021

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