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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medline Industries Inc
- Reason for Recall:
- Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2574-2021
Related Recalls
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.