Flexor Check-Flo Introducer recalled for misplaced radiopaque marker
Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect in marker positioning with no reported patient illnesses or injuries. The stated consequence is increased procedural time rather than patient harm, and the defect can be identified and managed during the procedure.
Plain-English summary
Cook Inc. is recalling Flexor Check-Flo Introducer, Introducer Set (RPN KCFW-6.0-35-45-RB, GPN G09908) from affected lot 13861362. The introducer sheath incorporates a hydrophilic-coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Affected introducers may be manufactured with the radiopaque marker band located just below the Check-Flo proximal fitting instead of at the distal tip. This manufacturing defect may not be identified until the device is placed in a patient and viewed under fluoroscopy, leading to increased procedural time.
Approximately 48 units were distributed domestically to Arkansas, Arizona, Connecticut, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Minnesota, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Texas, and Washington. Additional units were distributed internationally to Germany, Finland, Italy, the Netherlands, and Switzerland.
Healthcare facilities using this device lot should discontinue use and contact Cook Inc. for return and replacement instructions.
The recalled product
- Product
- Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
- Manufacturer
- Cook Inc.
- Hazard
- marker-misplacement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot 13861362
Distribution
Distributed in 17 states:
- AR
- AZ
- CT
- FL
- GA
- IL
- LA
- MA
- ME
- MN
- ND
- NJ
- NY
- OH
- PA
- TX
- WA
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27