Cook Incorporated: Approach Micro Wire Guides Recalled for Incorrect Expiration Dates

What You Should Do

1. Locate your Cook Approach CTO Micro Wire Guide or Approach Hydro ST Micro Wire Guide and check the catalog numbers and lot numbers on the packaging.
2. For Approach CTO Micro Wire Guides, check for catalog 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, or CMW-14-300-6G.
3. For Approach Hydro ST Micro Wire Guides, check for catalog numbers HMW-14-135-ST, HMW-14-190-ST, or HMW-14-300-ST.
4. Verify the lot numbers against the extensive list of affected codes, including series like 15763571, 15943888, 15858395, and those starting with 'NS' such as NS15849650.
5. Identify the UDI-DI codes on the label: 00827002507876, 00827002507883, 00827002507890, 00827002507869, 00827002507913, 00827002507920, 00827002507937, 00827002507906, 00827002529373, 00827002529380, or 00827002529397.
6. If your device is from an affected lot, do not use it and contact your healthcare provider or Cook Incorporated at 1-800-457-4500 for further instructions and potential replacement or refund.
7. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products