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

Is my product affected?

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

• UPC 10198459445941
• UPC 40198459445942

Check against the official notice below — it lists the full affected range.

Hazard

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.

Details from the source

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. Quantity: 135 units Lot/code info: UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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