FDAFDA recall Z-3137-2026 · Sep 23, 2026
Medline Industries, LP: Medline Convenience Kit: OPEN HEART A PACK recall
Recall found
Product
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Reason for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
- Quantity
- 135 units
- Distribution
- US Nationwide distribution in the state of CA.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-23
Source: openFDA enforcement record Z-3137-2026 · search recall number Z-3137-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.