United StatesMedline Convenience Kit: OPEN HEART A PACK (Product Number DYNJ43008N; UDI‑DI 10198459445941 each, 40198459445942 case; Lots 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372) distributed in California (135 units) is affected. The kits contain a Retrograde Coronary Sinus Perfusion cannula that may have a sterile barrier breach so sterility cannot be assured, and if a compromised pouch seal is not identified and the cannula is used there is a potential risk of infection or other complications including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
What's being recalled
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of CA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)