Medical Device Recall: Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP · July 23, 2026
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
US Nationwide distribution in the state of CA.
States Affected
NATIONWIDE
Quantity Affected
135 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3137-2026
Status: ongoing
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