Device product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Z-2012-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 104 kits
- Official record key
device-enforcement:Z-2012-2026
Official wording
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.
Code information: UDI/DI each 10889942214112, UDI/DI case 40889942214113, Lot Numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, 21BBL371.
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification