FDAJuly 23, 2026
Medline OPEN HEART A PACK Recall Over Retrograde Coronary Sinus Perfusion Cannulae Sterility Breach
FDA published this notice on July 23, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- July 23, 2026
- Recall class
- Class II
- Reason given by the agency
- 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.
- Official source
- the notice at its source
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Source: FDA.