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Medical Device

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Recall date: 2026-09-23 · Source: FDA_DEVICE
Brand / Firm
Medline Industries, LP
Product
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.
Units affected
135 units
Description
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
View official recall notice →