Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing defect affecting a critical device identifier. Although no injuries or illnesses have been reported, the misplaced radiopaque marker creates a risk-of-harm situation where proper device identification during fluoroscopy may be compromised.
Plain-English summary
Cook Inc. is recalling certain Flexor Check-Flo Introducer - Raabe Modification, Introducer Sets (RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069) due to a manufacturing defect affecting lot 13846597. In affected units, the radiopaque marker band is located just below the Check-Flo proximal fitting instead of at the distal tip where it should be positioned.
The misplaced marker band may not be identified until the device is placed in a patient and viewed under fluoroscopy during a medical procedure. When the marker cannot be properly visualized in its expected location, this leads to increased procedural time as clinicians attempt to locate the device tip.
Approximately 48 units of the affected lot were distributed in the United States, including to customers in 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.
Customers in possession of affected units should immediately cease use and contact Cook Inc. for device replacement or return instructions. Healthcare providers should review their inventory to identify affected devices and contact Cook with any questions about replacement.
The recalled product
- Product
- Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
- Manufacturer
- Cook Inc.
- Hazard
- manufacturing-defect
- device-misidentification
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 13846597
Distribution
Distributed in 17 states:
- AR
- AZ
- CT
- FL
- GA
- IL
- LA
- MA
- ME
- MN
- ND
- NJ
- NY
- OH
- PA
- TX
- WA
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