Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 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: 13101181, 13121311, 13141330, 13153425, 13159709, 13170659, 13175451, 13186259, 13205335, 13205336, 13205337, 13205338, 13205339, 13205340, 13205341, 13214445, 13217109, 13217110, 13219549, 13226821, 13226822, 13226823, 13226824, 13226825, 13262316, 13262318, 13262383, 13262384, 13262385, 13262386, 13262387, 13262388, 13265309, 13265310, 13265311, 13265312, 13265313, 13265314, 13265315, 13265316, 13265317, 13265319, 13265321, 13268016, 13268018, 13268019, 13268020, 13268021, 13268022, 13268023, 13268025, 13268026, 13268027, 13268029, 13276232, 13276234, 13276236, 13276243, 13279089, 13315183, 13346074, 13346097, 13391157, NS13108062
- 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-5.0-35-55-RB-HFANL1-HC, Order Number G56235 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: 13101181, 13121311, 13141330, 13153425, 13159709, 13170659, 13175451, 13186259, 13205335, 13205336, 13205337, 13205338, 13205339, 13205340, 13205341, 13214445, 13217109, 13217110, 13219549, 13226821, 13226822, 13226823, 13226824, 13226825, 13262316, 13262318, 13262383, 13262384, 13262385, 13262386, 13262387, 13262388, 13265309, 13265310, 13265311, 13265312, 13265313, 13265314, 13265315, 13265316, 13265317, 13265319, 13265321, 13268016, 13268018, 13268019, 13268020, 13268021, 13268022, 13268023, 13268025, 13268026, 13268027, 13268029, 13276232, 13276234, 13276236, 13276243, 13279089, 13315183, 13346074, 13346097, 13391157, NS13108062
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0595-2021
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