Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 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: 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856,
- 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-8.0-35-70-RB-HFANL1-HC, Order Number G56228 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: 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0609-2021
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