FDA recall Z-1119-2022
Steris Corporation · Class II · 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
Reason for recall
Product not approved for release for US distribution
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2022-03-22
- Report date
- 2022-06-01
- Termination date
- 2024-01-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mentor, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2022