- Recalling firm
- Medline Industries, LP
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
- Units affected
- 135 units
- Distribution pattern
- US Nationwide distribution in the state of CA.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3137-2026
- Recall initiated
- July 23, 2026
- FDA classification date
- September 10, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99583
- Last updated on HTM Vibe
- September 29, 2026