FDA DeviceClass IINotable
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCE
Description
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.
Hazard
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.
Remedy
4324 kits
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