Device product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Z-2032-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10400 kits
- Official record key
device-enforcement:Z-2032-2026
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 10884389388655, UDI/DI case 40884389388656, Lot Numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, 21BDA565.
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification