Terumo Cardiovascular Systems Corporation: Cardiovascular Procedure Kits Recalled for Faulty Pressure Relief Valves

What You Should Do

1. Identify if your facility has any of the affected cardiovascular procedure kits by checking the product and lot numbers on the packaging. Affected items include various Cardioplegia Sets and Perfusion Packs with part numbers such as 16010, 62974, 66312, 66342, 66388, and many others listed in the recall.
2. Check the GTIN numbers and specific lot codes (e.g., 2L05, 2L12, 2L19, 2P19, 2K15, 2M17) to confirm if your inventory is part of the recalled units.
3. Immediately stop using any affected cardiovascular procedure kits and quarantine them to prevent accidental use in medical procedures.
4. Contact Terumo Cardiovascular Systems Corporation at 1-800-262-3304 or visit their website for specific return instructions and information regarding replacement components.
5. Healthcare providers should consult with their surgical teams and medical staff to determine if any patients were treated with the affected kits and if follow-up care is necessary.
6. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
7. For general questions regarding this device recall, 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