Medline Industries, LP recalls Medline Convenience Kit: OPEN HEART A PACK
- Recalling company
- Medline Industries, LP
- Product
- Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 23, 2026
- Reported
- Sep 23, 2026
- Distribution
- US Nationwide distribution in the state of CA.
- Status
- Ongoing
- Quantity
- 135 units
- Lot / codes
- UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
- Company location
- Northfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3137-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3137-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.