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

Medical DevicesSource: FDA (device) · Date: 2026-09-23

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of CA.
Recall initiated
2026-07-23
Code info
UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
Product quantity
135 units
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
99583
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