Class II — Medline Industries, LP
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N |
| Quantity | 135 units |
| Distribution | US Nationwide distribution in the state of CA. |
| Initiated | 2026-07-23 |
| Classified | 2026-09-10 |
| Recall number | Z-3137-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medline Industries, LP (Z-3137-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99583/
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