Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 13089576, 13105053, 13130281, 13130282, 13135871, 13159711, 13159712, 13162740, 13166130, 13170660, 13175442, 13175443, 13186252, 13189278, 13192082, 13192083, 13192085, 13192086, 13192087, 13194970, 13194971, 13194973, 13194974, 13200438, 13203161, 13203162, 13203164, 13205342, 13205343, 13207358, 13207359, 13207361, 13207362, 13207363, 13207364, 13207365, 13207366, 13217123, 13219553, 13219554, 13223827, 13223828, 13226776, 13240001, 13243202, 13262322, 13276244, 13279106, 13304457, 13310767, 13315203, 13323502, 13329236, 13332175, 13337810, 13352475, 13360432, 13291884X, NS13077815, NS13077819, NS13105057, NS13105059, NS13192090, NS13226781, NS13315204, NS13376992
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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-5.0-35-70-RB-HFANL0-HC, Order Number G56220 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: 13089576, 13105053, 13130281, 13130282, 13135871, 13159711, 13159712, 13162740, 13166130, 13170660, 13175442, 13175443, 13186252, 13189278, 13192082, 13192083, 13192085, 13192086, 13192087, 13194970, 13194971, 13194973, 13194974, 13200438, 13203161, 13203162, 13203164, 13205342, 13205343, 13207358, 13207359, 13207361, 13207362, 13207363, 13207364, 13207365, 13207366, 13217123, 13219553, 13219554, 13223827, 13223828, 13226776, 13240001, 13243202, 13262322, 13276244, 13279106, 13304457, 13310767, 13315203, 13323502, 13329236, 13332175, 13337810, 13352475, 13360432, 13291884X, NS13077815, NS13077819, NS13105057, NS13105059, NS13192090, NS13226781, NS13315204, NS13376992
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0596-2021
Related Recalls
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa