Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
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.
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Medline Industries, LP
- Affected product
- Worldwide distribution.
- Risk or 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.
- Remedy or action
- UDI/DI each 10889942214112, UDI/DI case 40889942214113, Lot Numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, 21BBL371.
- Official ID
- Z-2012-2026