Food, drugs, devices › Medline Industries Inc
Device recall: NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Of
FDA enforcement event 88516 is a device recall by Medline Industries Inc of Northfield, IL, initiated 6 Aug 2021 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 25 Aug 2025. Initiation: voluntary: firm initiated. Medline Industries Inc has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries Inc, Northfield, IL.
Reason for recall
"Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2574-2021 | 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,… | 816,420 manifolds and stopcocks | Class II | Terminated | 6 Oct 2021 |
| Z-2575-2021 | NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14… | 816,420 manifolds and stopcocks | Class II | Terminated | 6 Oct 2021 |
Context
Other enforcement events for Medline Industries Inc
All 61 events for Medline Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Aug 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.