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 MA
Hazard
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
What You Should Do
Remedy
The recalling firm issued letters dated and mailed on 8/6/2021 notifying consignees of the issue and requesting they immediately check their stock for the affected product and destroy it.
Affected by this recall?
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Products
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 MAN
- Brand
- Medline Industries Inc
- UPC
- 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.
Units Affected
816,420 manifolds and stopcocks