Device product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
Z-2029-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 340 kits
- Official record key
device-enforcement:Z-2029-2026
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 10889942930883, UDI/DI case 40889942930884, Lot Numbers: 21GBA316, 21FBA411, 21DBI004, 21BBS142.
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification