Recall Z-2145-2026 ยท OEZ Cardiovascular Procedure Kit
Medline Industries, LP
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, M
| Date | May 8, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. |
| Quantity | 567675 kits |
| Distribution | US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.