Medline Convenience Kit: OPEN HEART A PACK recall: Foreign Material
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Why was Medline Convenience Kit: OPEN HEART A PACK recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372
- Product
- Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- Recalling firm
- Medline Industries, LP
- Quantity
- 135 units
- Distribution
- US Nationwide distribution in the state of CA.
- Recall date
- September 23, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)