Medline Open Heart A Pack Convenience Kit
The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Medline Industries, LP, of Northfield, Illinois, recalled its Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N, because 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.
The company began the recall on July 23, 2026, and the FDA classified it on September 10, 2026. The recall was added to the FDA's Enforcement Report on September 11, 2026, and in the FDA's weekly enforcement report on September 23, 2026. The 135 affected units were distributed in California.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
Medline Convenience Kit
- UDI-DI
- 10198459445941
- 40198459445942
- Lot
- 25HLA462
- 25HLA916
- 25JLA847
- 25LLA298
- 26CLA372
From the FDA notice
OPEN HEART A PACK, Product Number DYNJ43008N
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of California.
- Event ID
- 99583
- Recall No.
- Z-3137-2026
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Sterility failure
- Quantity recalled
- 135 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
