Device product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Z-2031-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 380 kits
- Official record key
device-enforcement:Z-2031-2026
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 10195327487546, UDI/DI case 40195327487547, Lot Numbers: 24KME456, 24HMJ900.
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification