Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
US Nationwide distribution in the state of CA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3137-2026