CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Namic Manifolds recalled by Medline Industries
Medline Industries is recalling Namic Manifolds, distributed nationwide in the US. The recall was initiated on 6 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2574-2021
- FDA event ID
- 88516
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2021
- FDA classified
- 24 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2021 | Recall initiated by company | |
| 24 Sep 2021 | Classified by FDA | +49 days |
| 6 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Namic Manifolds recalled?
Yes. Medline Industries recalled Namic Manifolds on 6 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2574-2021.
Why was it recalled?
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Which lots are affected?
Expiration dates 12/31/2023-6/30/2024. (1) REF 64038301 - Lot numbers 0000006342, 0000008482, 0000016519; UPN H965640383011 - Lot number 5642413; (2) REF 64038303 - Lot numbers 0000010144, 0000014189, 0000016524; UPN H965640383031 - Lot number 5642416; (3) REF 70037200 - Lot numbers 0000002033, 0000008570, 0000016521; UPN H965700372001 - Lot numbers 5649219, 5659335; (4) REF 70037202 - Lot numbers 0000014365, 0000016522; UPN H965700372021 - Lot numbers 5642417, 5642565, 5642566, 5642567, 5642568, 5643626, 5647596; (5) REF 70037301 - Lot numbers 0000002024, 0000006320, 0000010129; UPN H965700373011 - Lot number 5662011; (6) REF 70037303 - Lot numbers 0000002051, 0000006046; UPN H965700373031 - Lot numbers 5655475, 5662957, 5664026; (7) REF 70038200 - Lot numbers 0000001974, 0000006032, 0000010140, 0000014125; UPN H965700382001 - Lot numbers 5645162, 5649221, 5662013; (8) REF 70038202 - Lot numbers 0000007917, 0000010149, 0000016523; UPN H965700382021 - Lot numbers 5642414, 5649222, 5657918, 5660843; (9) REF 70038301 - Lot numbers 0000006189, 0000010147; UPN H965700383011 - Lot numbers 5642415, 5648171, 5649224, 5652296; (10) REF 70038303 - Lot numbers 0000006240, 0000008481, 0000010133, 0000010142, 0000014338; UPN H96570038301 - Lot numbers 5649225, 5650868; (11) REF 70039202 - Lot number 0000006312; UPN H965700392021 - Lot number 5662961; (12) REF 70039301 - Lot number 0000006055; UPN H965700393011 - Lot numbers 5642420, 5643629, 5652297, 5658658, 5662016; and (13) REF 70039303 - Lot number 0000016625.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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