Medline Industries, LP — Class II: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro
Medline Industries, LP has initiated a Class II recall for several dimensions of Medline Neuro Sponges after an internal review identified higher-than-expected endotoxin levels that may be out-of-specification.
This recall affects hospital neurosurgery departments, surgical centers, and distributors utilizing Medline Neuro Sponges (SKUs NEUROSPNG02, 05, 06, 07, 09, 11, 13, and 14).
Elevated endotoxin levels in neurosurgical products present a specific risk of inflammatory responses or pyrogenic reactions in sensitive central nervous system environments. For regulatory professionals, this highlight confirms the importance of rigorous internal monitoring and the potential for representative product testing to trigger broad-scale recalls across multiple product dimensions.
Identify and quarantine all affected SKUs within inventories. Conduct a reconciliation of distributed versus remaining units and evaluate the necessity of medical impact assessments for patients previously exposed to these specific lots. Review supplier quality or internal production controls regarding endotoxin monitoring.
Class II. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.. Product: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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