# FDA recall Z-2574-2021

> **Medline Industries Inc** · Class II · device recall initiated 2021-08-06.

## 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 H9

## Reason for recall

Potential for sterile barrier breach.  Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan,  People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom.

## Key facts

- **Recall number:** Z-2574-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-10-06
- **Termination date:** 2025-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2574-2021

## Citation

> AI Analytics. FDA recall Z-2574-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2574-2021. Source: US FDA. Licensed CC0.

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