Recall Z-2138-2026 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medline Industries, LP
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
| 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 | 7075 units |
| 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
| K782095 | STOPCOCKS, MANIFOLDS Namic, Jan 23, 1979 |