NAMIC Manifolds — Class II medical device recall Z-2574-2021
Terminated recall by Medline Industries Inc, reported 2021-10-06, distributed nationwide. Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to
| Recall number | Z-2574-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2025-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, GB, JP, KR, LB, LV, MY, NL, PA, PK, SG, TH, ZA |
| Quantity | 816,420 manifolds |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00965700373031 |
| Lot numbers | 0000001974, 0000002024, 0000002033, 0000002051, 0000006032, 0000006046, 0000006055, 0000006189, 0000006240, 0000006312, 0000006320, 0000006342, 0000007917, 0000008481, 0000008482, 0000008570, 0000010129, 0000010133, 0000010140, 0000010142, 0000010144, 0000010147, 0000010149, 0000014125, 0000014189, 0000014338, 0000014365, 0000016519, 0000016521, 0000016522, 0000016523, 0000016524, 0000016625, 5642413, 5642414, 5642415, 5642416, 5642417, 5642420, 5642565 and 39 more |
| Model numbers | 64038301, 64038303, 70037200, 70037202, 70037301, 70037303, 70038200, 70038202, 70038301, 70038303, 70039202, 70039301, 70039303, H965640383011, H965640383031, H965700372001, H965700372021, H965700373011, H965700373031, H965700382001, H965700382021, H96570038301, H965700383011, H965700392021, H965700393011 |
| Expiration dates | 2023-12-31 |
Product
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile. (5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (9) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038301, UPN H965700383011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (10) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038303, UPN H96570038301, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (11) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039202, UPN H965700392021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (12) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039301, UPN H965700393011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; and (13) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039303, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.
Reason for recall
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2574-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.