FDA Warns Medline Neurosurgical Products Have High Endotoxin Levels
The FDA said in a letter to healthcare providers that on March 13, Medline issued a customer letter stating higher than expected endotoxin levels have been identified on Medline branded neurosurgical pattie products, which suggests that out-of-specification endotoxin levels may be present in on-market products. "Use of the product may result in health hazards that may necessitate medical or surgical intervention, such as febrile response and/or local transient inflammation, hypotension, or nausea. Medline also updated their neuro sponge product pageExternal Link Disclaimer to state that they have initiated a recall of all SKUs in the Medline Branded neuro sponge category with no definite market re-entry date at this time," the agency said. Medline also updated their neuro sponge product page to state that it has initiated a recall of all products in the Medline Branded neuro sponge category with no definite market re-entry date at this time. The FDA recommends health care providers experiencing interruptions or shortages in supply of neurosurgical patties, sponges and strips develop strategies to conserve their use.
