FDA recall Z-1118-2022
Steris Corporation · Class II · device
Product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
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-1118-2022