Medline Open Heart Convenience Kit recalled for sterile barrier breach risk
What this means
Medline's Open Heart Convenience Kit (DYNJ43008N) contains a coronary cannula with a potential sterile barrier breach. If a compromised pouch seal isn't caught before use, the non-sterile device could cause infection or serious complications including blood cell breakdown, blood clots, or organ damage.
- Check your kit for lot numbers 25HLA462, 25HLA916, 25JLA847, 25LLA298, or 26CLA372.
- Inspect the pouch seal carefully before use.
- Do not use the kit if the seal appears compromised.
- Contact Medline or your hospital's medical device team for instructions.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3137-2026More Medline recalls
- FDA-Device2026-09-23Medline anesthesia L&D kits recalled for fungal contamination risk
- FDA-Device2026-09-23Medline Convenience Kits recalled for fungal contamination in sterile applicators
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.