Z-3137-2026 Class II Ongoing
FDA device recall Z-3137-2026 was initiated by Medline Industries, LP on July 23, 2026 and is designated Class II. 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 n… The recall status is ongoing. Affected quantity: 135 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372