Medline Industries Inc recalls NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifo

Recalled October 6, 2021 · FDA recall Z-2574-2021 · Medline Industries

Hazard

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

Units

816,420 manifolds and stopcocks

Sold at

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.

Description

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

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.

Manufacturer(s)

Medline Industries Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →