Drug recall
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
FDA recall event 99583 · Class II · Medline Industries, LP
Key facts
| Event ID | 99583 |
|---|---|
| Recall numbers | Z-3137-2026 |
| Recalling firm | Medline Industries, LP |
| Product type | Devices |
| Products | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 23, 2026 |
| Report date | Sep 23, 2026 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: