Cook Incorporated is recalling 30 units of Ultrathane Drainage Catheters because the product labels show incorrect expiration dates that extend beyond the device's actual shelf life. Using a medical device past its true expiration date can lead to material degradation, which may cause the device to fail or result in patient injury during drainage procedures. These catheters are used for medical drainage in applications such as nephrostomy, biliary, and abscess treatments. This recall involves the Mac-Loc and Cook-Cope types of the Ultrathane Locking Loop Multipurpose Drainage Catheters.
The incorrect expiration date may lead healthcare providers to use a catheter that has degraded over time, potentially causing the device to break, leak, or fail to function properly during a surgical procedure. While no injuries have been reported, using an expired sterile device increases the risk of infection or procedural complications.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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