🔍 RecallPedia

Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 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: 10332622, 10332623, 10335453, 10335456, 10338048, 10338049, 10338050, 10342579, 10342580, 10342581, 10342582, 10342590, 13002891, 13002897, 13006165, 13006166, 13006181, 13008773, 13008784, 13008785, 13008786, 13008787, 13011537, 13011538, 13014541, 13014545, 13020497, 13020498, 13020511, 13023868, 13023878, 13023879, 13029745, 13029746, 13029747, 13029748, 13029749, 13029750, 13029751, 13035275, 13039774, 13043788, 13043802, 13043803, 13043804, 13043805, 13043806, 13043807, 13047789, 13047790, 13050311, 13050324, 13050325, 13086346, 13086347, 13086348, 13089656, 13089657, 13094405, 13097678, 13097679, 13097681, 13097691, 13097692, 13101233, 13105097, 13105098, 13105099, 13105100, 13105101, 13126489, 13126490, 13126491, 13128737, 13128738, 13134895, 13134897, 13141007, 13141008, 13141009, 13141010, 13143117, 13143120, 13143121, 13143129, 13143130, 13143131, 13178615, 13178617, 13186365, 13186366, 13189358, 13192148, 13192149, 13195043, 13197524, 13197525, 13197526, 13197533, 13200500, 13205399, 13205415, 13205416, 13205417, 13205418, 13207558, 13207586, 13219603, 13221896, 13221903, 13223326, 13223327, 13223328, 13223329, 13223330, 13223331, 13223332, 13223333, 13226894, 13229771, 13229772, 13231878, 13231879, 13234846, 13234847, 13237736, 13240039, 13240048, 13240066, 13246623, 13246624, 13246625, 13249506, 13249507, 13249508, 13254754, 13260085, 13268159, 13274346, 13274363, 13274364, 13274365, 13276219, 13276220, 13276221, 13276222, 13279330, 13281720, 13281732, 13281733, 13284579, 13284580, 13284581, 13284582, 13284583, 13288184, 13288185, 13292062, 13294665, 13312741, 13312742, 13312750, 13315287, 13315288, 13315289, 13318101, 13318109, 13320658, 13320659, 13320660, 13320661, 13323519, 13323520, 13323521, 13323546, 13327092, 13327093, 13329060, 13329061, 13332072, 13332073, 13346140, 13346160, 13346161, 13346162, 13349095, 13349100, 13349125, 13352236, 13352237, 13352238, 13352239, 13352240, 13354220, 13363114, 13363115, 13363140, 13363141, 13363142, 13410269, 13458470, 13458471 Additional lot as of 1/14/21 - 13312743
  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 Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 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: 10332622, 10332623, 10335453, 10335456, 10338048, 10338049, 10338050, 10342579, 10342580, 10342581, 10342582, 10342590, 13002891, 13002897, 13006165, 13006166, 13006181, 13008773, 13008784, 13008785, 13008786, 13008787, 13011537, 13011538, 13014541, 13014545, 13020497, 13020498, 13020511, 13023868, 13023878, 13023879, 13029745, 13029746, 13029747, 13029748, 13029749, 13029750, 13029751, 13035275, 13039774, 13043788, 13043802, 13043803, 13043804, 13043805, 13043806, 13043807, 13047789, 13047790, 13050311, 13050324, 13050325, 13086346, 13086347, 13086348, 13089656, 13089657, 13094405, 13097678, 13097679, 13097681, 13097691, 13097692, 13101233, 13105097, 13105098, 13105099, 13105100, 13105101, 13126489, 13126490, 13126491, 13128737, 13128738, 13134895, 13134897, 13141007, 13141008, 13141009, 13141010, 13143117, 13143120, 13143121, 13143129, 13143130, 13143131, 13178615, 13178617, 13186365, 13186366, 13189358, 13192148, 13192149, 13195043, 13197524, 13197525, 13197526, 13197533, 13200500, 13205399, 13205415, 13205416, 13205417, 13205418, 13207558, 13207586, 13219603, 13221896, 13221903, 13223326, 13223327, 13223328, 13223329, 13223330, 13223331, 13223332, 13223333, 13226894, 13229771, 13229772, 13231878, 13231879, 13234846, 13234847, 13237736, 13240039, 13240048, 13240066, 13246623, 13246624, 13246625, 13249506, 13249507, 13249508, 13254754, 13260085, 13268159, 13274346, 13274363, 13274364, 13274365, 13276219, 13276220, 13276221, 13276222, 13279330, 13281720, 13281732, 13281733, 13284579, 13284580, 13284581, 13284582, 13284583, 13288184, 13288185, 13292062, 13294665, 13312741, 13312742, 13312750, 13315287, 13315288, 13315289, 13318101, 13318109, 13320658, 13320659, 13320660, 13320661, 13323519, 13323520, 13323521, 13323546, 13327092, 13327093, 13329060, 13329061, 13332072, 13332073, 13346140, 13346160, 13346161, 13346162, 13349095, 13349100, 13349125, 13352236, 13352237, 13352238, 13352239, 13352240, 13354220, 13363114, 13363115, 13363140, 13363141, 13363142, 13410269, 13458470, 13458471 Additional lot as of 1/14/21 - 13312743

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0611-2021

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