Recall record at a glance
| Official record | Z-2574-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Medline Industries Inc. |
| Report date | Oct 6, 2021 |
| Recall initiation date | Aug 6, 2021 |
| Quantity | 816,420 manifolds and stopcocks |
| Location | Northfield, IL, United States |
Official product description
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.
Why the product was recalled
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
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