Reported Sep 23, 2026 · Ongoing
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline Convenience KitOPEN HEART A PACK, Product Number DYNJ43008N
- Lot codes and dates
- UDI-DI
10198459445941 (each)40198459445942 (case)
- Lot Numbers
25HLA46225HLA91625JLA84725LLA29826CLA372
- UDI-DI
- Amount recalled
- 135 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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