Medline Convenience Kit recall
Medline Industries, LP recalled Medline Convenience Kit on September 23, 2026 because of the kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. It was sold nationwide.
Why it was 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's recalled
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Quantity: 135 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Medline Industries, LP, Northfield, IL
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the state of CA. - Status
- Ongoing
- Recall number
- Z-3137-2026
- Source
- U.S. Food and Drug Administration
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