🔍 RecallPedia

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 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: 13135824, 13140931, 13141304, 13141305, 13145950, 13145951, 13150436, 13150442, 13150443, 13153380, 13153383, 13153384, 13153385, 13155286, 13155289, 13155291, 13158203, 13158204, 13158208, 13162736, 13162737, 13163193, 13166157, 13166158, 13166159, 13172675, 13172676, 13172677, 13172678, 13175465, 13175466, 13175469, 13175470, 13175471, 13180815, 13180818, 13186322, 13186327, 13186328, 13189186, 13189191, 13189192, 13189193, 13189194, 13189198, 13189199, 13197483, 13200412, 13200413, 13200414, 13202954, 13205305, 13205306, 13207459, 13211825, 13211829, 13214442, 13214443, 13214444, 13217124, 13219557, 13219561, 13219562, 13219563, 13219564, 13221801, 13221808, 13221809, 13226802, 13226803, 13226804, 13229671, 13229678, 13229679, 13231822, 13234798, 13243204, 13243215, 13243216, 13243217, 13243218, 13243219, 13252359, 13260007, 13260018, 13262325, 13262326, 13265328, 13279083, 13279084, 13281529, 13281779, 13281780, 13281781, 13281782, 13288114, 13291865, 13294510, 13297239, 13301844, 13301845, 13301846, 13307175, 13307176, 13307177, 13310722, 13310723, 13310730, 13310731, 13312686, 13315170, 13315171, 13315172, 13318023, 13318033, 13318034, 13318035, 13332157, 13332158, 13334762, 13337772, 13337776, 13337777, 13337778, 13337779, 13337794, 13337795, 13342831, 13342837, 13342838, 13342839, 13342857, 13342858, 13342859, 13346085, 13348996, 13348997, 13348998, 13348999, 13349000, 13349001, 13352433, 13352440, 13352468, 13354239, 13354247, 13354248, 13354249, 13354250, 13354251, 13357224, 13357225, 13360405, 13360406, 13363206, 13363207, 13363215, 13363216, 13363217, 13369413, 13369414, 13369422, 13369423, 13372605, 13375223, 13375224, 13375225, 13376997, 13380390, 13380391, 13382717, 13384997, 13384998, 13391147, 13391148, 13391149, 13396148, 13398853, 13398854, 13398855, 13401842, 13407495, 13432838, 13375222X
  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-HFANL1-HC, Order Number G56236 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: 13135824, 13140931, 13141304, 13141305, 13145950, 13145951, 13150436, 13150442, 13150443, 13153380, 13153383, 13153384, 13153385, 13155286, 13155289, 13155291, 13158203, 13158204, 13158208, 13162736, 13162737, 13163193, 13166157, 13166158, 13166159, 13172675, 13172676, 13172677, 13172678, 13175465, 13175466, 13175469, 13175470, 13175471, 13180815, 13180818, 13186322, 13186327, 13186328, 13189186, 13189191, 13189192, 13189193, 13189194, 13189198, 13189199, 13197483, 13200412, 13200413, 13200414, 13202954, 13205305, 13205306, 13207459, 13211825, 13211829, 13214442, 13214443, 13214444, 13217124, 13219557, 13219561, 13219562, 13219563, 13219564, 13221801, 13221808, 13221809, 13226802, 13226803, 13226804, 13229671, 13229678, 13229679, 13231822, 13234798, 13243204, 13243215, 13243216, 13243217, 13243218, 13243219, 13252359, 13260007, 13260018, 13262325, 13262326, 13265328, 13279083, 13279084, 13281529, 13281779, 13281780, 13281781, 13281782, 13288114, 13291865, 13294510, 13297239, 13301844, 13301845, 13301846, 13307175, 13307176, 13307177, 13310722, 13310723, 13310730, 13310731, 13312686, 13315170, 13315171, 13315172, 13318023, 13318033, 13318034, 13318035, 13332157, 13332158, 13334762, 13337772, 13337776, 13337777, 13337778, 13337779, 13337794, 13337795, 13342831, 13342837, 13342838, 13342839, 13342857, 13342858, 13342859, 13346085, 13348996, 13348997, 13348998, 13348999, 13349000, 13349001, 13352433, 13352440, 13352468, 13354239, 13354247, 13354248, 13354249, 13354250, 13354251, 13357224, 13357225, 13360405, 13360406, 13363206, 13363207, 13363215, 13363216, 13363217, 13369413, 13369414, 13369422, 13369423, 13372605, 13375223, 13375224, 13375225, 13376997, 13380390, 13380391, 13382717, 13384997, 13384998, 13391147, 13391148, 13391149, 13396148, 13398853, 13398854, 13398855, 13401842, 13407495, 13432838, 13375222X

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0599-2021

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