Device product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Z-1119-2022
Product summary
- Event
- Event 90050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 152 cases
- Official record key
device-enforcement:Z-1119-2022
Official wording
Reason: Product not approved for release for US distribution
Code information: Lot Number: 202108
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Product not approved for release for US distribution