Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters.
Bloomington, Indiana-based Cook Medical’s field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo proximal fitting instead of the distal tip.
The company warns that the radiopaque marker band could be difficult to visualize prior to placement due to the introducer sheath material and color and the issue would likely only be identified after the device is placed in the patient and viewed under fluoroscopy. The problem could lead to increased procedural time because of the need to remove and replace the sheath.
Check-Flo introducer sheaths in lot number 13861362 with reference part number KCFW-6.0-35-45-RB and order number G09908 are affected.
Cook Medical recommends that users identify, quarantine and return the device to the company.