Reported Oct 6, 2021 · Terminated
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold,…
Medline Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries Inc · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
25 of 25 products
| Model / number | Product as published |
|---|---|
64038301 | Expiration dates 12/31/2023-6/30/2024. (1) - Lot numbers 0000006342, 0000008482, 0000016519 |
| — | UPN H965640383011 - Lot number 5642413 |
64038303 | (2) - Lot numbers 0000010144, 0000014189, 0000016524 |
| — | UPN H965640383031 - Lot number 5642416 |
70037200 | (3) - Lot numbers 0000002033, 0000008570, 0000016521 |
| — | UPN H965700372001 - Lot numbers 5649219, 5659335 |
70037202 | (4) - Lot numbers 0000014365, 0000016522 |
| — | UPN H965700372021 - Lot numbers 5642417, 5642565, 5642566, 5642567, 5642568, 5643626, 5647596 |
70037301 | (5) - Lot numbers 0000002024, 0000006320, 0000010129 |
| — | UPN H965700373011 - Lot number 5662011 |
70037303 | (6) - Lot numbers 0000002051, 0000006046 |
| — | UPN H965700373031 - Lot numbers 5655475, 5662957, 5664026 |
70038200 | (7) - Lot numbers 0000001974, 0000006032, 0000010140, 0000014125 |
| — | UPN H965700382001 - Lot numbers 5645162, 5649221, 5662013 |
70038202 | (8) - Lot numbers 0000007917, 0000010149, 0000016523 |
| — | UPN H965700382021 - Lot numbers 5642414, 5649222, 5657918, 5660843 |
70038301 | (9) - Lot numbers 0000006189, 0000010147 |
| — | UPN H965700383011 - Lot numbers 5642415, 5648171, 5649224, 5652296 |
70038303 | (10) - Lot numbers 0000006240, 0000008481, 0000010133, 0000010142, 0000014338 |
| — | UPN H96570038301 - Lot numbers 5649225, 5650868 |
- Amount recalled
- 816,420 manifolds and stopcocks
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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