Device product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
Z-2009-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 306 kits
- Official record key
device-enforcement:Z-2009-2026
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: Medline Kit Number SKU DYNJ86657A: UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704.
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification