The Recall Desk
HighFDA (Devices)·Z-0346-2025·Announced 2024-11-20

Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels

Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.

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 medical device with labeling error. Incorrect expiration dates on guide wire labels create risk of device use beyond safe operational life. This is a risk-of-harm product where injury has not yet been reported, placing it at score 3 per the rubric.

Plain-English summary

Cook Incorporated is recalling the Approach CTO Micro Wire Guide (catalog prefix CMW). This is a guide wire medical device. The recall affects 2,005 units distributed in the United States and 1,145 units distributed overseas, involving multiple reference part numbers and lot numbers.

The affected device lots have labels that state incorrect expiration dates. This labeling error creates risk that medical professionals may use devices based on inaccurate expiration information.

Healthcare facilities and clinical staff who use these devices should verify actual expiration dates against the lot numbers listed in this recall. Facilities in possession of affected lots should remove them from clinical use and contact Cook Incorporated for instructions regarding replacement or disposal.

The recalled product

Product
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Manufacturer
Cook Incorporated
Category
Medical Device — Guide Wire
Hazard
  • mislabeling

Distribution

Distributed nationwide across the United States.

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