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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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.
The affected introducers may have been incorrectly cut to length or not trimmed and inspected properly. This defect poses a risk during medical procedures, potentially leading to complications.
There have been no reported injuries or deaths associated with this recall. The potential for serious complications remains a concern.
Stop using the affected introducers immediately. Contact Cook Medical or your healthcare provider for further instructions on returning the product.
For more information, contact Cook Incorporated at the customer service number provided on their website or check the recall notice at the FDA site.
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