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NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H96564...

FDA Device Recall #Z-2574-2021 — Class II — August 6, 2021

Recall Summary

Recall Number Z-2574-2021
Classification Class II — Moderate risk
Date Initiated August 6, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries Inc
Location Northfield, IL
Product Type Devices
Quantity 816,420 manifolds and stopcocks

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.

Reason for Recall

Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

Distribution Pattern

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.

Lot / Code Information

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.

Other Recalls from Medline Industries Inc

Recall # Classification Product Date
Z-0358-2022 Class II EVLP Convenience Pack/Kit Oct 27, 2021
Z-0362-2022 Class II Bedside PICC CDS Convenience Kit Oct 27, 2021
Z-0360-2022 Class II Major Vascular CDS Convenience Kit Oct 27, 2021
Z-0359-2022 Class II Neuro Convenience Kit Oct 27, 2021
Z-0361-2022 Class II Venous Access Pack-LF Convenience Kit Oct 27, 2021

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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