Cook Medical recalled 7,952 Flexor Check-Flo introducers and sets on November 26, 2025. The devices may have been manufactured out of specification, potentially posing serious risks to patients. Health care providers and patients should stop using these products immediately.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Letter
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Flexor Check-Flo introducers and guiding sheaths are designed for use in medical procedures to facilitate the introduction of other devices. They are commonly used in minimally invasive surgeries and vascular access procedures.
The recall is due to manufacturing errors where devices may have been cut incorrectly or not trimmed properly. This can lead to problems during medical procedures, potentially jeopardizing patient safety.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the affected devices immediately to avoid possible complications during medical procedures.
Reference part numbers and lot numbers can typically be found on the product's packaging or label.
Expect a 4-6 week timeline for receiving refunds or replacements.
Keep records of your communications with Cook Medical, including dates and content of discussions.
The recall affects Flexor Check-Flo introducers and sets with various reference part numbers including KCFW-9.0-18/38-45-RB-ANL0-HC and KCFW-10.0-35-45-RB-HFANL0-HC. These devices were distributed worldwide and sold through multiple retailers.
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